Daily News for Neuros, Nurses & Savvy Patients!

Oprah Co. Sued for Multiple Sclerosis Discrimination

2010-08-13T19:37:00.000-07:00

(Posted By: Josi Creek)

A woman who worked for Oprah Winfrey's OWN network claims she was subjected to a hostile work environment because she suffers from Multiple Sclerosis.
According to a lawsuit filed today in Los Angelas Superior Court, Catherine Dunn was an assistant at OWN beginning in August 2008. She claims that during her time there, she was "subjected to a hostile work environment" because of her MS.

She claims she was forced to take a stress leave as well of a leave of absence because her MS symptoms were exasperated because of the workplace stress.

When she was out on leave, Dunn claims she was replaced by "a non-disabled and younger employee."

Dunn is suing for wrongful termination, among other things. She is asking for unspecified damages.

So far ... no comment from Oprah & Co.

Clinical Trials Necessary to Approve a Copaxone Generic

2010-08-06T20:02:00.002-07:00

(Posted By: Josi Creek)

Any generic of Teva’s blockbuster multiple sclerosis treatment Copaxone would need clinical trials to gain approval, the company says in response to speculation that the FDA might approve a generic Copaxone using the same criteria it applied to generic Lovenox. “In the case of Copaxone and other complex molecules, there are no acceptable … tests either in humans or animals that can be relied upon except for complete clinical tests, which reflect the clinical outcome in multiple sclerosis,” Teva CEO Shlomo Yanai said.

Investigators Recruiting Globally For Phase II Study Of Oral Multiple Sclerosis Pill

2010-08-05T15:28:00.000-07:00

(Posted By: Josi Creek)

Investigators are recruiting 400 people with relapsing-remitting MS for a study evaluating three doses of ACT-128800, an oral compound that affects immune function, versus placebo. The study sponsor is Actelion Pharmaceuticals, Ltd.
Rationale: Multiple sclerosis involves an immune system attack on the brain and spinal cord. ACT-128800 binds to a docking site (sphingosine-1-phosphate receptor 1, or S1P1 receptor) on immune cells, including T cells and B cells (lymphocytes) that have been implicated in causing nervous system damage in MS. The once-a-day pill induces lymphocytes to remain in lymph nodes, where they can do little harm, preventing these cells from migrating into the brain and spinal cord. A similar drug, fingolimod (Novartis International AG) was recently recommended for U.S. FDA Approval by an FDA advisory committee, based on positive results from two large-scale phase III clinical trials. ACT-128800 is more selective for the S1P1 receptor.

Eligibility and Details:Participants may include individuals aged 18 to 55 with a diagnosis of relapsing-remitting MS. Patients with ongoing bacterial, viral, or fungal infection, or a history or presence of malignancy will be excluded. Additional criteria - including previous treatment or medical conditions that might exclude individuals from participating - can be obtained by contacting the study investigators via the email listed below.

Participants will be randomly assigned to receive one of three doses of ACT-128800 once daily for 24 weeks, or placebo. The primary outcome being measured is the effect of the drug on disease activity observed on MRI scans. Secondary outcomes being measured are ACT-128800's effect on relapse rate, time to first relapse, and safety/tolerability.

Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please email medinfo@actelion.com.

Sites are recruiting participants worldwide, and in the following U.S. cities:

Akron, OHBaltimore, MDBurlington, VTCincinnati, OHColumbus, OHIndianapolis, INKansas City, KSKirkland, WALatham, NYNew York, NYNewark, NJPhiladelphia, PAPortland, ORRaleigh, NCRichmond, VASacramento, CASarasota, FLSchenectady, NYScottsdale, AZShawnee Mission, KSSt. Louis, MOStanford, CAStony Brook, NYTucson, AZWorcester, MA

Novel multiple sclerosis theory (CCSVI) dealt a blow by studies

2010-08-02T19:51:00.001-07:00

(Posted By: Josi Creek)

A novel theory about the cause of multiple sclerosis — one that quickly led to millions of dollars in research pledges and an increasingly popular, though unproved, treatment — took a hit Monday from two studies calling the premise into question.

The theory, proposed last year, had gained traction in a field desperate for research advances. It suggests that multiple sclerosis can be traced to obstruction in the veins carrying blood from the brain back to the heart — leading to nervous-system damage and causing the hallmark symptoms of muscle weakness, decreased coordination and vision problems.

Despite the fact that multiple sclerosis has long been acknowledged as an immune-system disorder, patients immediately leaped for MS endovascular surgery to open blocked or narrowed veins in the neck. The National MS Society has reported that one patient undergoing such treatment died.

Now research published online in the Annals of Neurology undermines the theory — called chronic cerebrospinal venous insufficiency by its creator, Italian researcher Paolo Zamboni.

In one study, conducted by German scientists, ultrasound-imaging tests of the veins around the brain and nervous systems of 56 multiple sclerosis patients found that blood flow was normal in all but one person. A control group of 20 healthy patients had similar blood flow.

The second study, conducted in Sweden, used a different type of imaging test to compare blood flow in MS patients and a group of healthy people; both had similar amounts of blood-vessel blockage.

"These are important, cautionary papers," said Dr. Stephen L. Hauser, chairman of the department of neurology at UC San Francisco, who was not involved in the research. "It should help us all to step back and wait for additional word before any patient with MS moves forward."

The theory picked up steam late last year when Zamboni, director of the Vascular Diseases Center at the University of Ferrara in Italy, published a paper in the Journal of Vascular Surgery suggesting that the majority of 65 MS patients studied had abnormal blood drainage from the brain and spinal cord — and that angioplasty to open blocked veins improved symptoms. Zamboni theorized that poor blood flow causes blood to reverse and flow back into the brain, setting off inflammation and immune-system damage.

Dr. Florian Doepp, of University Hospital Charité in Berlin, did not find that to be the case.

"We had nearly completely different results than Dr. Zamboni," Doepp said.

"You can't really explain the disease with this hypothesis," he added. "In theory, it could explain a little bit. But it's not the whole story of multiple sclerosis. MS is a complicated disease."

In the other study, Dr. Peter Sundstrom, a neuroscientist at Umea University in Sweden, used magnetic resonance imaging to look for abnormal blood flow in the jugular vein. He found no significant differences in blood flow in 21 patients with multiple sclerosis and 20 healthy people.

"I see no point in doing angioplasty if there are no stenoses," or narrowing of the veins, Sundstrom said. "These two studies published in Annals today question if there is an increased prevalence of venous blockage in MS at all."

A third study, reported in April at the American Academy of Neurology annual meeting, produced ambiguous results. In that study, more than half of the MS patients who had participated in imaging studies showed signs of abnormal blood flow compared to about 23% of healthy patients and 42% of people with other neurological conditions. That study is ongoing at the University of Buffalo.

As many as 1,500 people with the disease in the United States and Canada have now sought treatment for venous insufficiency, according to some estimates. Multiple sclerosis affects approximately 400,000 Americans.

The surgery to open blocked blood vessels — by inserting a tiny balloon or stent into the veins — carries the risk of infection, blood clotting and excessive bleeding. Officials at Stanford University stopped offering it last year as a result of complications in some patients.

In this country, the treatment is offered in clinical trials only at the University of Buffalo and at a vascular medical center in Albany, N.Y. It's not known how many doctors are offering the treatment outside such trials.

Gene Variant May Increase Severity of Multiple Sclerosis

2010-08-02T19:46:00.000-07:00

(Posted By: Josi Creek)

A new study shows a gene variant may increase the severity of multiple sclerosis (MS) symptoms. The research will be published in the August 3, 2010, issue ofNeurology®, the medical journal of the American Academy of Neurology.

For the study, researchers screened the oligoadenylate synthetase (OAS1) gene in 401 people with MS, 394 people without MS and 178 people receiving the MS treatment beta interferon.

On the analysis of the OAS1 gene, 63 percent of people with MS had the AA genotype compared to 57 percent of people without MS. The GG genotype was found in 37 percent of people with MS compared to 43 percent of people without the disease.

While the OAS1 gene was weakly associated with disease susceptibility, the study found that people who had the AA genotype had earlier relapses and increased disease activity compared to those without the genotype.

"While we don't understand why some patients vary so widely in their disease activity, this genetic association may give us clues to help direct future research," said study author Margaret O'Brien, PhD, with St. Vincent's University Hospital in Dublin, Ireland.

The study also found people who had the GG genotype had less disease activity and fewer relapses. "It's possible that the GG genotype may protect against increased disease activity in people with MS, but more research is needed," said O'Brien.

The study was supported by Science Foundation Ireland, the Health Research Board of Ireland and MS Ireland.

FDA Approves First Human Trial of Embryonic Stem Cells

2010-08-01T08:30:00.000-07:00

(Posted By: Josi Creek)

The U.S. Food and Drug Administration approved the world’s first human clinical trial of a therapy involving embryonic stem cells, the biotechnology company behind the planned trial announced Friday.

California-based Geron Corporation has been given the green light to proceed with its trial on a therapy for patients with spinal-cord injury. The trial involves injecting a stem-cell treatment into patients with severe spinal cord injury with the hope that it would help damaged nerve cells regrow and eventually allow patients to regain movement.

Both opponents and proponents of embryonic stem cell research highlight the fact that the FDA had originally approved the study in January 2009 and the trial was scheduled to begin last summer. But Geron found that animals used in a preclinical study had developed small cysts that appeared with “a higher frequency” than other studies, resulting in the FDA delaying the trial from proceeding.

Even proponents of embryonic stem cell research raised concern about this trial, noting its history with animals.

Embryonic stem cell research is controversial because it requires the destruction of the embryo during the process of harvesting the stem cells. Many pro-life groups, therefore, argue it is unethical and equate the research with abortion because it destroys another potential life. They also argue that adult stem research is an alternative that is both ethical and has proven results.

“Despite the efforts that are made to deny it, science continues to show us that the embryo is a human being in the making,” said Elio Sgreccia, emeritus head of the Pontifical Academy for Life, on Radio Vatican.

However, proponents of the research method highlight that embryonic stem cells are highly versatile and can develop into any tissue in the body. They, therefore, hope it can be used to develop organs for transplant and help regrow damaged nerves.

Under President George W. Bush, federally funded embryonic stem cell research was highly restricted. He twice vetoed legislations that would expand federal funding for the research. But President Obama in 2009 repealed Bush’s order that prevented the National Institutes of Health from funding the research beyond the cell lines that existed at the time.

Obama allowed greater freedom and federal funds for scientists who want to research using embryonic stem cell research.

Geron’s therapy, if successful, has the potential to help Alzheimer’s disease and multiple sclerosis, among other health problems.

The company has not scheduled a date when the trial will begin, but it wants to start this year. Geron has spent 15 years and more than $150 million on this therapy treatment, according to the San Jose Mercury News.

Multiple Sclerosis To Be Diagnosed Earlier – Study

2010-08-01T08:24:00.000-07:00

(Posted By: Josi Creek)

UCI immunological study finds earlier way to diagnose multiple sclerosis (MS).

Assessing for the increasing presence of antibodies that blocks energy production in neurons, UCI immunologists discovered that it can be used also in diagnosing multiple sclerosis at an earlier stage of the disease than the usual diagnostic tools.

The research demonstrated how these blockers initiate disintegration of both axons and neurons, leading to the removal of myelin, neurons’ protective coating.

The research was headed Yufen Qin, assistant professor of neurology.

The studyreported that demyelination, or the removal of neuronís protective covering, is the main determinant in detecting ME using spinal fluid tests at present.

Quantifying the GAPDH inhibiting enzyme or antibodies, Qin says, could result in the fast and efficient treatment of MS, a commonly known disparaging disease that has the central nervous system as its usual target.

The study appears online in The Journal of Immunology.

Teriflunomide and Glatiramer Acetate Combination Safe and Effective Against Relapsing-remitting Multiple Sclerosis

2010-07-23T05:03:00.000-07:00

(Posted By: Josi Creek)

The current long-term therapies used to treat multiple sclerosis (MS) are administered intramuscularly or subcutaneously, producing local adverse effects at the sites of injection. Hence, the development of an orally administered drug would offer greater convenience and be more acceptable to patients. Teriflunomide is one of five such orally administered disease-modifying agents (used against rheumatoid arthritis) currently under investigation. Now, a Phase II trial conducted by researchers at the Mount Sinai School of Medicine reports teriflunomide to be safe and effective when used in conjunction with glatiramer acetate for the treatment of relapsing-remitting multiple sclerosis (RRMS).

CCSVI Trial Set for This Fall

2010-07-23T04:59:00.001-07:00

(Posted By: Josi Creek)

With health officials clamouring for more scientific research before green-lighting the new liberation treatment for multiple sclerosis (MS), local supporter and cardiovascular-thoracic surgeon Sandy McDonald is stepping up to provide it.

“I’m working with colleagues to design a double-blinded study for assessing CCSVI and its treatment,” he said, anticipating a more extensive test group than the preliminary trials first published by pioneering Italian vascular surgeon Paolo Zamboni.

“We have two neurologists, three vascular surgeons and interventional radiologists interested in being involved.”

In the process of gaining Institutional Review Board approval, McDonald said the trial is moving forward as quickly as possible, and could even start in the fall, but there are “a lot of hurdles to get past before we get there.”

Zamboni rocked the global MS community last November by linking blocked veins in the head, neck and shoulders to the symptoms of the disease – a condition he dubbed Chronic Cerebrospinal Venous Insufficiency (CCSVI). He took his hypothesis a step further when his team performed balloon angioplasties to free the blood flow. The reported results detailed alleviated MS symptoms.

McDonald travelled to Italy to study Zamboni’s unique vein-scanning techniques first-hand to avoid the false negatives often obtained through more traditional imaging.

He has since provided the non-subsidized tests at no cost to patients or the health-care system upon physician referral to his Alliance Boulevard clinic.

The actual procedure, however, is currently not available in Canada.?

Earlier this year, McDonald requisitioned six MS-related angioplasties for patients showing the tell-tale vein abnormality and associated iron debris, with follow-up visits revealing encouraging results across the board.

Some reported increased mobility and speech, and another claimed no further symptoms at all.

One young man’s parents had installed an elevator in their house to help their son’s mobility prior to the procedure. Now he is not only able to climb stairs without hesitation, but McDonald reports his patient has since moved into his own home where he lives independently.

After the positive results in his first few cases, McDonald and the interventional radiologists who performed the procedure decided to take a brief hiatus to first establish a method of capturing the data and tracking the results in order to share their findings.

Although the timeframe has stretched on longer than he initially anticipated, the surgeon now hopes to accept qualified patients into a full-scale research trial, complete with a treatment arm, come fall.

Nevertheless, McDonald said the approximately 1,000 successful liberation treatments done to date around the world should be enough to encourage the Canadian health-care system to allow the treatment as an option to patients – even if on a pay-per-service basis.

Upward Mobility with REX

2010-07-19T11:37:00.000-07:00

(Posted By: Josi Creek)

When Robert Irving was diagnosed with Multiple Sclerosis it was the catalyst for him and his childhood friend, Richard Little, to put turn their engineering skills to the task of developing an exoskeleton that was a practical standing and walking alternative to wheelchairs. The result is REX, an exoskeleton made of strong, lightweight materials that is designed to support and hold a person comfortably as they move.

Users strap themselves in to the robotic legs with a number of Velcro and buckled straps that fit around the legs along with a belt that fits around the user’s waist. While most robotic exoskeletons we’ve looked at, such as the HAL, augment human motion, this is generally not an option for wheelchair-bound users so REX is controlled using a joystick that sits at the wearer’s waist level. When wearing REX users can stand up, walk, move sideways, turn around, go up and down steps, as well as walk on flat, hard surfaces including ramps and slopes. It is powered by a custom-made rechargeable battery that will typically provide two hours of active use on a full charge. To extend running time the battery can be easily swapped out for a fully charged one.

Meat, Sausage and other foods can heighten risks of Multiple Sclerosis

2010-06-27T11:35:00.000-07:00

(Posted By: Josi Creek)

Opinion from examination of information from seven EU countries introduced today by German epidemiologist Dr. Klaus Lauer, at the 20th Meeting of the European Neurological Society (ENS) in Berlin, Germany, stated that the facts presented as of currently are not affirmed informal link, but is an expressive implication that a link possibly does exist and needs to be completely researched.

Research data had implied that particular industrial manufacture foods such as chocolate, jam, margarine and sausage, corresponds statistics with heightened chances of multiple sclerosis.

During the “ecological study”, the epidemiological examination of information gathered of major regions or population groups, information on industrial food manufacturing in seven countries were analyzed for likely MS relationships with reversed results.

A major heightened occurrence was found associated with MS and the dispersion of raw vegetable oils, fats, butter, cheese, condensed milk, canned vegetables and more.

Decreased risks of MS actually was witnessed in other countries with greater manufacturing of canned fish, macaroni and other related commodities.

Dr. Lauer states that because ecological studies do not examine a single person but only huge groups an an absolute random link a conclusion is not possible from them. That would require more comprehensive examination of individuals to examine that further on who acquire MS, did indeed had eaten larger amounts of provisions and stayed healthy. However, the epidemiological link that currently had been discovered, in any incident is a major implication that the possibility does exist, and it is of vital need to be researched more in depth.

Multiple Sclerosis is a conceivably incapacitating disease in which the body immune system absorbs repeatedly the guarded wrapping that covers the nerves, hampering transmissions between the brain and the rest of the body. This can lead to finally lead to the nerves decaying. There is no treatment to correct the problem.

Currently it is estimated that there are between 250,000 to 350,000 persons in the United States that have been diagnosed with MS. It is estimated that there will be 250 new cases diagnosed each wee.

A lot of persons with MS suffer from a vast array of nutritional deficiencies, a lot of them are the same deficiencies that can cause osteoporosis along with a lot of MS symptoms.

Researchers have constantly been looking into many avenues of what possibly causes MS to occur. Among some possibilities have been viral elements and nutrition.

Lack of Vitamin D has been proved to cause same symptoms of MS in mice. Many persons with MS have also shown a lack of Vitamin D. Lack of Vitamin B 12 has also been indicated in MS patients.

Proper nutritional diets are one recommended therapy for persons with MS. Seeking out a dietician about nutritional needs can be very helpful with the symptoms of MS.

Multiple Sclerosis treatment, daclizumab in final clinical trial stage

2010-06-23T12:05:00.000-07:00

(Posted By: Josi Creek)

Abbott Laboratories and its Massachusetts biotech partner have launched a final-stage clinical trial of their experimental treatment for multiple sclerosis.

The first patient — out of 1,500 needed worldwide — was enrolled last month in the U.S. The drug, daclizumab, is being developed for monthly injection under the patient’s skin by North Chicago-based Abbott and Cambridge-based Biogen Idec.

The trial is important because the drug industry is searching for new ways to change the course of the debilitating autoimmune disease, rather than merely treating the symptoms, as most products on the market do. Multiple sclerosis is a common neurological disorder in which a patient’s immune system starts to attack the central nervous system. It affects an estimated 2.5 million people worldwide.

“Despite significant advances in MS therapy, many patients continue to experience disease activity,” said Dr. Ludwig Kappos, lead investigator for the Abbott and Biogen-funded study and head of MS research at University Hospital in Basel, Switzerland. “The MS community is eager for new treatment approaches.”

Biogen already has a well-known therapy on the market called Tysabri, proven to be effective by slowing progression of the disease in most patients studied and reducing MS flare-ups. That has helped the drug become a blockbuster that will generate more than $1 billion in annual sales for the first time this year.

But Tysabri also has a rare but deadly side effect. It has been linked to causing a fatal disease called progressive multifocal leukoencephalopathy, or “PML.”

As of June 7, Biogen said, 55 people have developed PML and 11 of them have died out of about 68,000 people on Tysabri. The U.S. Food and Drug Administration is closely monitoring Tysabri, but has maintained the drug’s benefits outweigh its risks.

In clinical trials so far with daclizumab, there are no known cases of PML, according to Abbott and Biogen. The drug is a monoclonal antibody that works by attaching itself to disease cells.

Biogen said enrollment of MS patients in the final stage clinical trial will be completed next year. Some analysts say daclizumab could be submitted to the FDA in the next three to four years for possible approval.

NIH Denies Request For Federal Funding to Study New Stem Cell Lines

2010-06-22T14:09:00.000-07:00

(Posted By: Josi Creek)

A private lab’s request for federal funds to study 47 new stem cell colonies has been denied by National Institutes of Health director Francis Collins. The rejection comes after an advisory committee recommended against the approval citing the request violated strict ethical guidelines. Many scientists had hoped for an approval that would give them the ability to study various mutations of diseases. Diseases that were proposed to be studied included Huntington’s disease, cystic fibrosis and multiple sclerosis. Scientists believe the studying of these stem cell lines could have led to treatments for many of these incurable and often times deadly conditions.

The stem cells were developed from embryos donated to the private clinic Reproductive Genetics Institute in Chicago. Couples donated the embryos they did not want to use because they were found to have genetic defects. The couples signed waivers that included vague wording about what the embryos may have been used for. The waiver also negated a person’s right to sue the clinic for any reason. The wording in the waiver is not in line with new guidelines signed into law by President Obama soon after he took office. Many scientists and researchers feel the updated guidelines are still very restrictive and are limiting the amount of research that could be done.

Private labs will still be allowed to study the lines with private funding. Collins did give the green light on eight other new stem cell lines. This brings the total number of stem cell lines approved for study to 75.

Multiple Sclerosis in a War Zone

2010-06-21T08:54:00.000-07:00

(Posted By: Josi Creek)

Can multiple sclerosis attacks be minimized in a war zone?

*An earlier study has shown that the stress of the Second Lebanon War in Israel increased the frequency of attacks in multiple sclerosis (MS) patients. The present study reveals that a potential way to minimize MS exacerbation is by directly coping with the situation. *

Multiple sclerosis patients who directly confronted the stress of the Second Lebanon War suffered fewer attacks than those who chose to cope with the situation by focusing on feelings. This has been shown in a new study carried out by researchers of the University of Haifa, the Technion-Israel Institute of Technology and Carmel Medical Center. "Because there is no cure for multiple sclerosis to date, it is important to uncover all the factors that impact the recurrence of attacks," said Prof. Eli Somer of the University of Haifa, one of the authors of the study.

The study, which Prof. Somer carried out alongside Dr. Daniel Golan, Sara Dishon, Limor Cuzin-Disegni and Dr. Idit Lavi of Carmel Medical Center and Prof. Ariel Miller of the Technion, examined how MS patients living in the north of Israel coped during the Second Lebanon War. The results of the first stage of the study, which were recently published in the scientific journal Multiple Sclerosis, revealed that the ongoing stress of the war increased the number of MS attacks in patients who were exposed to rocket fire. The current stage of the study has examined 156 patients who have undergone regular therapy at the Center for Multiple Sclerosis at the Carmel Medical Center and who were living in the attacked north of Israel during the war.

The results have shown that patients who chose to use "direct coping and planning" to counter the stress factor – by preparing the shelter or protected area, stocking up on food and medications, adjusting their medical appointment schedule, and the like – suffered significantly less exacerbation of MS symptoms than patients who chose to cope with the situation on an emotional level, with relaxation techniques, requesting emotional support, or prayer.

"Patients who focused their coping on emotional wellbeing when a more direct approach was necessary, suffered more flare-ups of the disease than patients who identified the challenges that the falling missiles were presenting, and regarded the situation as an opportunity for planning and direct action," Prof. Somer noted.

The study has also found that women with MS tended to turn to emotional support, religion and willfully diverting thoughts more than men. Nevertheless, there was no difference between the numbers of men and women who chose "direct coping and planning".

"Coping directly is how a person takes real action in order to change an unwanted situation. Multiple sclerosis patients who chose to view the war as a controllable situation that requires action, instead of seeing it as an uncontrollable threat, suffered fewer attacks of the disease," said Prof. Somer, adding that now it is necessary to investigate whether the acquisition of psychological coping skills can stall the progression of this disease.

GW Pharmaceuticals Sativex Cannabis is Psychoactive Free

2010-06-20T15:52:00.000-07:00

(Posted By: Josi Creek)

Even if you were to track down the location and break into the computer-controlled greenhouse, the cannabis plants you would find at GW Pharmaceuticals' top-secret farm would be unlikely to give you the high you were hoping for.

"The chances are you'd end up with a plant that has no psychoactive potential anyway. That's the ultimate irony," says Justin Gover, managing director of the Aim-listed biotech business, which is understandably secretive about the whereabouts of its marijuana.

But while GW's genetically unique cannabis plants might leave you frustratingly sober, it is their non-psychoactive properties that are altogether more interesting.

For a decade, GW has been developing Sativex – a medicine derived from chemicals in cannabis, known as cannabinoids, which have been shown to ease the muscle stiffness associated with multiple sclerosis.

Despite the closely-monitored production process, the road to regulatory approval has been rocky. In 2005 Sativex won clearance in Canada for the treatment of neuropathic pain, making it the world's first cannabis medicine to get the green light. Approval in Europe, however, has been hit by a string of regulatory delays.

But last Friday GW confirmed that the Medicines and Healthcare Products Regulatory Agency in the UK had finally given Sativex the go-ahead. Approval here should be followed by Spain and other European countries. Analysts at Piper Jaffray forecast that peak sales could reach £121m in Europe and Canada combined.

Speaking in the weeks prior to MHRA's decision, when GW knew the regulator had no major issues with Sativex, Mr Gover told The Daily Telegraph approval in the UK would mark the culmination of "a great deal of effort".

"MS is a very difficult condition to study in clinical trials so this has probably been one of the most complicated developments undertaken by the industry," he said.

GW was founded in 1998 in response to concerns about MS patients who risked prosecution when they smoked cannabis to try to help ease pain and muscle stiffness.

"Everyone knows there are patients who see [smoking cannabis] as their only effective treatment option. The patients know, the Government knows and the reason for this is not because people with MS decide they wish to smoke joints," said Mr Gover. "They are in the unfortunate position of doing so because medication in MS treatment is poor – there's been no innovation for decades."

In the late 1990s, he added, it became clear that the Home Office was receptive to finding a legal medicinal solution for these patients. Against that background Dr Geoffrey Guy agreed to establish a company to look at developing a prescription cannabis-derived medicine that would meet the rigorous standards of regulators.

A Home Office licence to conduct the research was granted in 1998 and GW was born. But even then, funding was hard to come by, says Mr Gover – who joined GW, where Dr Guy is now chairman, in 1999.

While trials have shown that Sativex helps reduce spasticity in MS patients, it is not the only condition that GW's cannabis plants could potentially help to treat. GW has also discovered therapeutic potential for schizophrenia, epilepsy and types of diabetes.

For now, GW is delighted at having finally got the UK regulatory green light. "Sativex is not going to cure MS," says Mr Gover. "But what this medicine can do is it makes your life tolerable again. It doesn't work for everyone - it's not a miracle - but it is a worthwhile innovation and we're genuinely delighted."

Study: Quality of care in Multiple Sclerosis

2010-06-20T14:12:00.003-07:00

(Posted by: Josi Creek)

Study: Sativex effective on spasticity in people with multiple scleros

2010-06-19T12:04:00.000-07:00

(Posted By: Josi Creek)

Study: Alzheimer’s Drug Memantine Not Effective in treating Multiple Sclerosis Cognitive Impairment

2010-06-19T12:02:00.000-07:00

(Posted By: Josi Creek)

Two-year study of cervical cord volume and myelin water in primary progressive multiple sclerosis

2010-06-19T09:50:00.002-07:00

(Posted By: Josi Creek)

Study: Strains of Epstein-Barr virus infecting multiple sclerosis patients

2010-06-19T09:48:00.000-07:00

(Posted By: Josi Creek)

High-dose immunoablation with stem cell transplant in aggressive multiple sclerosis: a 10 year study

2010-06-19T09:37:00.000-07:00

(Posted By: Josi Creek)

Study: Psychiatric Symptoms at the onset of Multiple Sclerosis

2010-06-19T09:34:00.002-07:00

(Posted By: Josi Creek)

GW Pharmaceuticals cannabis-based drug Sativex approved

2010-06-18T14:02:00.000-07:00

(Posted By: Josi Creek)

A ground-breaking cannabis-based drug for treating symptoms of multiple sclerosis has been approved in Britain, in a landmark decision for its creator GW Pharmaceuticals.

The Aim-listed biotech company has been developing Sativex, which uses compounds extracted from marijuana plants, for more than a decade and has finally been granted a licence from the UK regulator.
Clinical trials have shown that Sativex, which is sprayed under the tongue, reduces spasticity in multiple sclerosis patients who do not respond adequately to existing therapies.
t became the world's first cannabis medicine to win regulatory clearance when it was approved in Canada in 2005 for neuropathic pain, but its roll-out in Britain – and other European markets thereafter – is a larger sales opportunity.
Last month, GW Pharmaceuticals indicated that the medicine would be approved by the end of June, with the final stages of the approval process involving only finalising product's packaging.
At the time, Dr Geoffrey Guy, chairman of GW, said: "The first six months of this year have proven the most important in GW's history, in which we have made material progress towards Sativex's launch in Europe and generated positive cancer pain data."
Although the market was anticipating approval in late June, Friday's news sent shares up 11pc to a four-year high of 143p in early afternoon trading. By the bell, shares were up 12 – or 9.3pc – to 141p.
A regulatory green light in Spain is expected shortly after the British approval.
Sativex is to be marketed in Britain by Germany's Bayer and in the rest of Europe by Spain's Almirall.
Analysts at Piper Jaffray have previously said that UK regulatory approval would trigger the first commercial sales and a £10m milestone payment from Bayer.
The broker anticipates that sales of Sativex in multiple sclerosis spasticity could reach £121m in Europe and Canada alone.

Novartis' Gilenia Pill May Shake Up Global MS Market

2010-06-18T07:23:00.001-07:00

(Posted By: Josi Creek)

Novartis AG's novel multiple sclerosis pill Gilenia holds the potential to shake up the $10 billion multiple sclerosis market and give the Swiss pharmaceuticals giant a cutting edge over rivals such as Irish drug maker Elan Corp. PLC , U.S.-based Biogen Idec Inc. and Germany's Merck KGaA.

The once-daily pill that promises to improve the lives of thousands of patients who suffer from the disease that debilitates the central nervous system has good chances to become the gold standard after a U.S. regulatory panel earlier this month recommended the drug for approval.

Despite raising safety concerns, the U.S. Food and Drug Administration's panel, in an unanimous vote, found the drug to be so effective as to allow it to become a first-line multiple sclerosis treatment despite side effects such as lung, heart and eye problems.

This, analysts say, raises the likelihood the FDA in September will fully back Gilenia's marketing launch that could come as early as in the third quarter of 2010 and net more than $1 billion in sales for Novartis.

The FDA panel's decision was a positive surprise and will act as a confidence booster for the Swiss pharma giant, which with the help of Gilenia may curb the sales drop it faces when its two top medicines--heart drug Diovan and cancer medicine Gleevec--lose patent protection over the next few years.

Analysts have hitherto been skeptical that Gilenia will make a deep impact, as early-stage trials raised the specter that the drug's side-effects could negate its benefits, limiting the sales and profit potential for the drug or even annihilating its chances to win approval.

But after the U.S. drug panel's verdict, the market's view is slowly changing and analysts have started to upgrade their forecasts that range between $1 billion to $3.5 billion.

"The strong endorsement [from the FDA panel] sets the stage for Novartis to shake up the multiple sclerosis market which is projected to grow to $15 billion by 2015," said Karl-Heinz Koch of brokerage Helvea. "We believe there is significant upside to our above consensus $1.4 billion sales forecast."

Analysts also welcomed Gilenia's potential to become a first-line treatment, thus hurting existing players, who are set to lose massive market share.

"The Gilenia recommendation for approval was expected, but the first line status wasn't", said Ian Hunter of Goodbody Stockbrokers. "The implication is that it is a greater setback for drugs already on the market." According to his estimates, Elan, for example, could lose some 10% of its patient base.

Other market leaders could suffer too as think tank Datamonitor expects Gilenia to become the leading multiple sclerosis therapy by 2016 and could net sales of more than $1 billion.

To date, the market for multiple sclerosis, which affects about 2.5 million people worldwide, is led by firms such as Biogen, Merck Serono, Bayer AG ( BAYN.XE), Elan and Teva Pharmaceutical Industries Ltd (TEVA.TV).

Teva and Sanofi-Aventis SA's (SAN.FR) own the market's best-selling drug Copaxone, which had more than $2.8 billion in sales in 2009. Biogen's Avonex also had more than $2 billion in annual revenue, while Bayer's Betaseron and Merck's Rebif had more than $1 billion in sales.

Most of these drugs, however, go with side-effects that could prove crippling for them once Gilenia is on the market. While many existing drugs need to be administered through a daily injection or infusion, the medicines also cause flu-like symptoms, a condition many patients dislike although it isn't dangerous.

Gilenia's pill form is believed to appeal to both patients and doctors because it's easier to administer and analysts say the lack of flu-like symptoms could even help Novartis expand the market, as many early-stage patients avoid taking some of the existing drugs because of the hampering side-effects.

"I believe the drug will be approved and will become a success because it is administered orally and is very efficacious," said Andrew Weiss, pharma analyst at Bank Vontobel. Still, he warns that Gilenia's dose related side-effects could prove a stumbling block and even delay the drugs approval. Weiss puts the approval probability at 50%, while he sees non-probabiltiy adjusted peak sales at about $2.9 billion.

Concerns about the drug's side effects have diminished after the FDA's panel decision, they but haven't fully abated--partly because the FDA asked Novartis to provide more research data and to consider lowering the drug's dosage to reduce side effects.

Fears that the drug could falter in late stage or even after approval are fueled by the fact that late-stage setbacks for multiple sclerosis drugs medicines are common.

For example, one year after the launch of multiple sclerosis drug Tysabri, Biogen and Elan had to pull off the drug from the market due to serious side effects such as brain tumors. The drug was later reintroduced but has since failed to live up to the high hopes of its producers. Also, Merck's oral multiple-sclerosis drug needed be resubmitted after the FDA rejected approval, saying Merck's filing was incomplete.

For brokerage Bernstein, these recent drug setbacks could serve to postpone Gilenia's market introduction. Also, the brokerage expects that Novartis' post- marketing efforts to highlight the drug's side effects will be strenuous. Nevertheless, the drug holds blockbuster potential and the brokerage sees sales of more than $1 billion by 2015.

Biogen Reports 6 More Brain Infection Cases In Tysabri Users

2010-06-16T14:56:00.000-07:00

(Posted By: Josi Creek)

Biogen Idec Inc. (BIIB) disclosed six more cases of a rare brain infection in multiple sclerosis patients on Tysabri, which it sells with Elan Corp. (ELN), bringing the total number of cases to 55 as of June 7.

The Cambridge, Mass., biotech company reported no additional deaths in patients that have developed progressive multifocal leukoencephalopathy, or PML, keeping the total at 11.

Tysabri is considered a highly effective therapy for MS, and its sales growth is important to the future of both Biogen and Elan. But sales have been slower than first anticipated because of concerns about the risk of PML, which led to the drug's 18-month market withdrawal beginning in 2005.

The overall global rate of PML infection is about 0.77 per 1,000 patients, Biogen said, which falls within the 1-in-1,000 rate previously seen in clinical trials and implied on the drug's label.

Shares of Biogen added 23 cents Wednesday to $48.35, while the American Depositary Shares of Elan slid 11 cents to $5.04.

Of the 55 cases Biogen reported, 20 were in the U.S., 32 in the European Union and three in other areas.

Biogen provides monthly updates on the number of PML cases in patients taking Tysabri.

A patient's risk of getting PML increases with the number of monthly infusions that he or she receives, something the Food and Drug Administration highlighted in a January safety update. The agency concluded that the benefits of the medicine continue to outweigh the risks.

The most recent monthly update translates to a rate of 1.24 cases per 1,000 for patients on the drug for a year or longer, but rises to 1.76 per 1,000 for those on the drug at least two years.

The rate of incidence is about 0.35 cases per 1,000 patients on the drug for between one and two years and 1.47 per 1,000 for those taking the drug between two and three years.

Breakthrough Finding from Israel may Lead to Earlier Diagnosis Multiple Sclerosis

2010-06-16T08:51:00.000-07:00

(Posted By: Josi Creek)

A breakthrough finding from Israel may lead to earlier diagnosis, more effective intervention, and perhaps even a cure for the autoimmune disease multiple sclerosis.

"Those who will develop MS will show a different blood signature from those who will not," Prof. Anat Achiron, director of the Multiple Sclerosis Center at Sheba Medical Center.

Multiple sclerosis (MS) has devastated the lives of two million people around the world. The disease is more prevalent in cold climates and attacks twice as many women as men. There is currently no cure. Now, research from Israel may pave the way for a diagnosis before symptoms appear and debilitation sets in. Earlier diagnosis of the disease will allow earlier medical intervention - and perhaps even lead to a cure.

Prof. Anat Achiron of Tel Aviv University's Faculty of Medicine and director of the Multiple Sclerosis Center at Sheba Medical Center has uncovered a new way of detecting MS biomarkers in the blood. Her findings were published in the journal Neurobiology of Disease and are expected to pave the way for a diagnosis of MS before symptoms can appear, allowing for earlier treatment.

MS attacks the central nervous system and eventually renders most patients disabled. The National MS Society estimates that there are currently about 400,000 cases in the US. In Israel there are an estimated 5,000 cases, according to the Israel Multiple Sclerosis Society.

"We are not yet able to treat people with MS to prevent the onset of the disease but knowledge is power," Achiron says. "Every time we meet a new patient exhibiting symptoms of MS, we must ask ourselves how long this has been going on. We can diagnose MS by brain MRI, but we've never been able to know how 'fresh' the disease is," she says.

Identifying MS a decade before symptoms appear

If doctors can predict the onset of MS early enough, intervention therapies using immunomodulatory drugs such as Copaxone (produced by Israel's Teva Pharmaceuticals) or beta-interferon drugs that stave off MS symptoms might be used.

"We theorized that if we looked at the gene expression signature of blood cells in healthy people, we could look for possible biological markers that characterize those who subsequently developed MS," Achiron explains.

Examining blood samples of 20 19-year-old Israelis who were inducted into the army as healthy soldiers, and the nine of them who later developed MS, Achiron and her team at Sheba were able to use a "high throughput analysis" with more than 12,000 gene transcripts expressions. The screening compared similarities and differences in the blood of those who developed MS and those who did not, eventually establishing biological markers.

"Those who will develop MS will show a different blood signature from those who will not," states Achiron. "When we compared the gene expression signatures, we saw a similar pattern of the same working biological processes."

These early genetic markers may now be used to test for MS up to nine years before healthy young adults start developing symptoms. And because MS is thought to have a genetic component and a tendency to be found in siblings, Achiron foresees that the biomarkers will be used as a tool for brothers and sisters of patients.

Clues for early intervention

Why test in advance of a cure? "The idea is that we'll know more about the genetics of MS through this new discovery, with the hope that early intervention therapies may be more effective, and help advance medicine toward a cure," responds Achiron. This new insight into who will develop MS in the future is a first step on the path of finding a cure to the disease.

By the time a person notices symptoms, significant and irreversible nerve damage has already occurred. MS is classified as an autoimmune disease that afflicts the brain and spinal cord. Symptoms vary, because the location and severity of each attack can be different, and until now, there has been no way of knowing who it will strike.

The disease causes the body's immune system's T cells to mistakenly regard the myelin sheath around our body's neurons as foreign, so the immune system starts attacking the sheath, causing neurons to short circuit.

Two of the most important drugs that shorten multiple sclerosis attacks were developed in Israel, and Tel Aviv University is considered a center of excellence in MS research. Other researchers in the study include David Magalashvili and Anna Feldman of Tel Aviv University, and Drs. Itamar Grotto and Ran Balicer of the Israel Defense Forces.

Study Provides Evidence that Add-on Rituximab Reduces Gadolinium-enhancing Brain Lesions in Multiple Sclerosis.

2010-06-16T08:41:00.000-07:00

(Posted By: Josi Creek)

This is a study that shows very promising results for Rituximab.

Zamboni Says Vein Procedure Should be Offered in Clinical Trial

2010-06-16T07:49:00.000-07:00

(Posted By: Josi Creek)

People with multiple sclerosis should be able to have surgery on blocked neck veins as part of a clinical trial, says the Italian doctor who pioneered what has become known as the liberation therapy.

Dr. Paolo Zamboni talked to MPs on the House of Commons health committee on Tuesday. He maintains the procedure has resulted in better cognitive and motor function — and fewer symptoms of chronic fatigue — among people with MS who were treated with balloons to open up blocked neck veins.
Zamboni calls the condition "chronic cerebrospinal venous insufficiency," or CCSVI.
His research suggests that narrowed or blocked veins cause blood to move backward, or reflux, back into the brain and spine, causing damage that results in the symptoms shown by some MS patients.
"It is not responsible not to proceed with [the] treatment," Zamboni said by videoconference.
Zamboni said the vein procedure should be offered in a randomized clinical trial under the supervision of an ethical committee.
The MS Society of Canada announced last week that it is spending $700,000 on four studies to determine if there is a link between blocked veins and MS, before it will support surgical treatment. The society says researchers elsewhere in the world haven't been able to reproduce Zamboni's findings.

Evaluation needed

The society wants more people assessed for blockages that are objectively evaluated by doctors, said spokeswoman Karen Lee.
Research needs to include people who receive vein treatment to see whether they improve, just as a drug therapy would be compared with a placebo, said Dr. Robert Maggisano, a vascular surgeon at Sunnybrook Health Sciences Centre in Toronto.
"We're wasting time and money, and certainly not helping our people, who are going overseas to get treatment, when we should be able to do the studies in a blinded fashion within Canada," Maggisano said.
Alain Beaudet, president of the Canadian Institutes of Health Research, said the institute is seeking proposals for a blinded, randomized control trial that includes the procedure. The deadline for proposals is mid-August.
The government committee also heard from Dr. Marian Simka, of Euromedic in Krakow, who is part of a team that charges $10,000 for a scanning and surgery package. After doing about 400 vascular surgeries since last fall, Simka said 80 to 90 per cent of MS patients have experienced improvement.

Biogen Idec Announces Enrollment of First Patient in Oral Therapy Combination Trial in Multiple Sclerosis

2010-06-15T08:44:00.000-07:00

(Posted By: Josi Creek)

Biogen Idec today announced enrollment of the first patient in a multicenter Phase II clinical trial designed to evaluate its investigational oral therapy BG-12 (dimethyl fumarate) in combination with commonly used first-line treatments in patients with relapsing-remitting multiple sclerosis (RRMS). The trial, called EXPLORE, will evaluate the safety and tolerability of BG-12 when administered with beta interferons (IFNB) or glatiramer acetate (GA) to patients who continue to have evidence of disease activity despite receiving consistent monotherapy for at least a year ,

"An ongoing treatment challenge in MS is that many patients continue to experience disease activity despite being on therapy," said Alfred Sandrock, M.D., Ph.D., Senior Vice President of Neurology Research and Development at Biogen Idec. "The goal of the EXPLORE trial is to evaluate whether BG-12 may be a safe and effective agent to use in combination with other MS therapies, an important consideration for patients for whom new treatment strategies are needed."

BG-12 is the first compound in trials for the treatment of MS that has been shown to activate the Nrf2 transcriptional pathway. Experimentally, the Nrf2 pathway has demonstrated neuroprotective and anti-inflammatory properties. Activation of this pathway in MS patients may potentially prevent further cell damage and tissue loss caused by the disease. Preclinical studies have shown that activation of the Nrf2 pathway defends against oxidative-stress induced neuronal death, protects the blood-brain barrier and supports maintenance of myelin integrity in the central nervous system. Central nervous system inflammation and damage may trigger the symptoms common in RRMS such as fatigue, cognitive deterioration and physical disability.

Data from the Phase IIb study in RRMS, combined with experimental data showing BG-12's ability to activate the Nrf2 pathway, continue to support its evaluation as a monotherapy in two extensive ongoing Phase III MS studies, DEFINE and CONFIRM, which are fully enrolled. These data also support its further investigation as a combination therapy in EXPLORE.

"The MS community is eager for new treatment options for this debilitating disease," said Robert Fox, M.D., Staff Neurologist and Medical Director at the Cleveland Clinic Mellen Center for Multiple Sclerosis Treatment and Research. "BG-12 may offer patients an additional treatment strategy. Its potential to both reduce inflammation and promote neuroprotection, its safety data to date, as well as its oral administration, support this study of BG-12 as a possible combination therapy for MS."

"The EXPLORE trial is another demonstration of Biogen Idec's commitment to MS," said Dr. Sandrock. "We have one of the most extensive MS pipelines in the industry, with multiple programs that target pathways thought to be critical in treating MS. This pipeline includes late-stage programs such as BG-12, PEGylated interferon beta 1a, and daclizumab, earlier-stage programs such as anti-LINGO, and several preclinical programs."

Genzyme's MS drug, Alemtuzumab gets FDA fast track

2010-06-15T08:37:00.000-07:00

(Posted By: Josi Creek)

Genzyme's multiple sclerosis drug candidate, Alemtuzumab was granted fast track status by the Food and Drug Administration, the company said Monday.

The FDA grants fast track status to drug candidates that are designed to treat serious diseases, and which may be superior to current therapies. Fast track status includes additional collaboration between Genzyme and the FDA, and will allow Genzyme to submit portions of its application for the drug alemtuzumab as they are completed, rather than when all clinical testing is complete.

It also means alemtuzumab could get approved more quickly. Drugs that receive fast track status are more likely to get a priority review, which is complete in six months instead of the usual 10 months.

Study: Changes in B- and T-cells & Chemokine Levels With Rituximab Treatment in Multiple Sclerosis

2010-06-15T07:21:00.001-07:00

(Posted By: Josi Creek)

"In subjects with multiple sclerosis, B cellsare critical for T-cell trafficking into the central nervoussystem and may alter the process by influencing chemokine productionwithin the central nervous system."

Study: Mental Activity protects against disease-related cognitive impairment associated with multiple sclerosis.

2010-06-15T07:14:00.001-07:00

(Posted By: Josi Creek)

Study: Stem Cell Transplant Fails to Halt Demyelination: Inflammation of Multiple Sclerosis

2010-06-15T07:08:00.001-07:00

(Posted By: Josi Creek)

"Demyelinating and inflammatory activities of MSpersisted after allo-HSCT (allogeneic hematopoieticstem cell transplantation) in all of the patients with MS. Activeand chronic active MS lesions exhibited significantly highernumbers of CD3⁺ T cells and CD8⁺ cytotoxic T cells and significantlyhigher scores of CD68⁺ microglia/macrophages than did chronicinactive lesions or normal-appearing white matter. The normal-appearingbrains of allo-HSCT recipients who did not have MS were foundto have significantly higher numbers of CD3⁺ T cells and CD8⁺cytotoxic T cells and higher scores of CD68⁺ microglia/macrophagescompared with the controls; however, no demyelination was identifiedin these non-MS samples."

Elan dealt a blow as rival drug, Gilenia, approved

2010-06-12T14:32:00.000-07:00

(Posted By: Josi Creek)

ELAN, the Athlone-based pharmaceuticals company, has been dealt a blow after a rival to one of its leading drugs was approved by US regulators. The share dealt 2.5pc lower in New York yesterday.

Gilenia, a drug used to treat multiple sclerosis, was approved unanimously yesterday by the Food and Drug Administration drugs advisory committee as part of the process that will see the drug eventually reach the market in the US and worldwide.

While the approval was expected, the committee unexpectedly approved the drug as a potential first-line therapy, adding to the competition for Elan's Tysabri. Gilenia is made by Swiss company Novartis.

Bloxham stockbrokers were pessimistic about Tysabri's future. "With Tysabri revenues already slowing in recent months, this announcement will do little to boost investor sentiment in the stock and will lead to further cuts in projected future Tysabri revenues."

Ian Hunter at Goodbody said up to 10pc of patients now on Tysabri may switch to Gilenia. "But we believe that Tysabri's undoubtedly superior efficacy will continue to attract patients when they experience disease breakthrough over time on other MS drugs, including Gilenia," he said.

Virus can make immune cells attack nerves in multiple sclerosis

2010-06-12T08:31:00.000-07:00

(Posted By: Josi Creek)

In young adults afflicted with multiple sclerosis (MS), a virus infection can incite the body to attack its own nerve tissue by activating unusual, disease-fighting cells with receptors for both viral and nerve proteins.

The dual-receptor observation indicates how brain and spinal cord nerve damage could be triggered in susceptible young adults with MS.

University of Washington Department of Immunology scientists Qingyong "John" Ji, Antoine Perchellet, and Joan M. Goverman conducted the study,

This is thought to be the first study to reveal a mechanism for autoimmune disease that depends on destroyer immune cells expressing dual receptors for a normal protein made by the body and a pathogen.

People with multiple sclerosis might lose their ability to see, walk, or use their arms, depending on which nerves are affected.

In healthy people, the immune system is kept in check to tolerate the usual proteins and cells in the body, much like an eager watch dog is put on a leash and trained to ignore friends and neighbours, yet still protect the family.

"Autoimmunity is believed to arise from an accidental breakdown in this tolerance of the body's own proteins. This breakdown is triggered by something in the environment, most likely a pathogen," Nature quoted Goverman as saying.

In the new study, the researchers genetically engineered mice that over-produce a certain type of white blood cell from a group known as killer T cells.

The specific killer T cells examined in this study were CD8+ T cells.

Researchers engineered mice to over-produce CD8+cells that recognized myelin basic protein, a predominant protein in the myelin sheath that covers nerves.

The major question investigated in the study was whether the genetically engineered mice would exhibit a disease that resembled multiple sclerosis.

The researchers infected the mice with a virus that has itself been engineered to produce myelin basic protein.

This infection should activate the CD8+T cells to first attack the virally infected cells making myelin basic protein to eliminate the virus, then kill other cells that make myelin basic protein to wrap around nerves.

Killing those cells would destroy the myelin sheath.

As expected, the mice developed a multiple sclerosis-like disease.

But the researchers were surprised when viruses lacking the myelin basic protein also triggered the disease.

Additional cross-breeding experiments revealed the existence of two receptors on a few of the CD8+T cells.

These cells, engineered specifically to bind to myelin basic protein, also built their own receptors for viruses, and could recognize both.

When exposed to cells infected with viruses, they would bind to and destroy them using one receptor.

In fact, some of these double-agent cells then would head elsewhere to bind their other receptor to cells producing myelin basic protein and ruin the coats on nerve cells.

"These results demonstrate a role for dual-receptor cells in autoimmunity," noted the authors.

The study also points to why a ubiquitous viral infection could leave most people without any lasting effects, but trigger autoimmunity in genetically predisposed individuals.

The findings open a new perspective on the proposal that multiple sclerosis is virally induced, despite the inability to detect infectious virus in the central nervous system of multiple sclerosis patients.

The study was published in Nature Immunology. (ANI)

Natalizumab an Alternative for Those in Whom Other MS Treatments Have Failed

2010-06-11T17:23:00.000-07:00

(Posted By: Josi Creek)

A new study suggests that patients with relapsing-remitting multiple sclerosis (RRMS) in whom previous treatment regimens have failed remain stable or show improvement when switched to treatment with natalizumab (Tysabri, Novartis).

In Natalizumab, considered very effective, is still viewed as an alternative treatment because of cases of progressive multifocal leukoencephalopathy that have been reported with treatment.

In this report, the researchers conducted a retrospective medical record review of 39 RRMS patients in whom previous treatments have failed. Patients were followed up for a minimum of 6 months to a maximum of 24 months.

Neurologic examinations and the EDSS were performed every 6 months. Eleven patients were previously treated with glatiramer acetate (Copaxone), 16 with interferon beta-1b (Betaseron), 11 with interferon beta-1a (Avonex: 3 patients; Rebif: 8 patients), and 1 with azathioprine (Imuran). Some patients may have received concomitant steroid treatment.

Participants had a median EDSS score of 3.0 and median counts of T2 lesions and black holes of 18 and 4. The researchers found no statistically significant changes in EDSS scores or MRI changes at 6, 12, 18, and 24 months.

At 24 months, 54% of patients had unchanged T2 counts, whereas 38% had improved counts, and 8% had worsened counts compared with month 0. There were no changes in black holes in most patients.

Overall, 87% of RRMS patients showed stable to improved MRI scans, and 59% had stability or improvement in EDSS scores.

Alternatives Important

"It's important to know [that there are alternatives] in a disease like MS," Robert P. Lisak, MD, professor of neurology at Wayne State University, Detroit, Michigan, who attended the presentation, told Medscape Neurology.

"If a drug is no longer working or the patient doesn't want to take it, the physician isn't stuck in a position of saying, 'there's nothing I can do for you,'" he added.

The study was supported by the Consortium of Multiple Sclerosis Centers. Mr. Ettensohn has disclosed no relevant financial relationships. Disclosures for coauthors appear in the abstract. Dr. Lisak reports he is part of a group that receives funding from Novartis, makers of natalizumab.

Consortium of Multiple Sclerosis Centers (CMSC) 24th Annual Conference and the Third Joint Meeting of Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS): Abstract S35. Presented June 4, 2010.87% of patients who had previously been treated with disease-modifying therapies (DMTs), treatment with natalizumab conferred stability or improvement in magnetic resonance imaging (MRI) scans. In addition, 59% of patients showed stability or improvement in Expanded Disability Status Scale (EDSS) scores.

"We're looking at patients who failed first-line treatment," Marc Ettensohn, a medical student at the University of Louisville in Kentucky, who presented the results, told Medscape Neurology. The stability or improvements in patients in this series, he said, "is saying a lot about the drug and its efficacy. I think this is probably one of the most effective drugs for those who fail first-line treatments."

The results were reported here at the Consortium of Multiple Sclerosis Centers 24th Annual Conference and the Third Joint Meeting of Americas Committee for Treatment and Research in Multiple Sclerosis.

Tried and Failed DMTs

Natalizumab has previously been shown to reduce new or newly enlarging T2-hyperintense lesions (T2 lesions) and improve EDSS scores in treatment-naive RRMS patients. However, most patients receiving natalizumab have received DMTs that have failed.

Team to test theory of vein efficiency in Multiple Sclerosis patients, and how to detect it

2010-06-11T17:16:00.000-07:00

(Posted By: Josi Creek)

B.C. doctors will be part of a $2.4-million, two-year research study to look at whether a controversial treatment for multiple sclerosis is legitimate.

A team of researchers from the University of B.C., Vancouver Coastal Health Research Institute and the University of Saskatchewan has been selected by the Multiple Sclerosis Society of Canada and the National MS Society (U.S.) to assess whether a syndrome known as chronic cerebrospinal venous insufficiency (CCSVI) has a role in MS.
“We’re planning on doing diagnostic studies to confirm how common is this CCSVI phenomenon,” said Dr. Tony Traboulsee, leader of the research team.
The MS doctors and patient community have been shaken up by Italian doctor Paulo Zamboni, who claims that treating CCSVI has had beneficial results with MS patients.
Zamboni’s treatment, which involves using an angioplasty-type treatment on veins, is reported to have improved the condition of some MS patients.
It has resulted in MS patients booking trips to Poland, Bulgaria and India to get the treatment.
The Canadian study will involve 200 people, 100 with MS and 100 without, to see if the CCSVI is a factor.
Traboulsee said the study will not involve treatment of the condition.
“The idea of the test if to find out if MS people have this and what’s the best way to detect it,” he said.
He said that people with MS should not spend tens of thousands going to Eastern Europe and India to get the treatment without knowing if it will work.
“People aren’t doing this as research, but are doing it for profit,” he said.
Still, Traboulsee said he understands why people don’t want to wait.
He said once the research study is complete, further testing will be needed to decide on treatment, if any.

FDA panel recommends approval of first oral drug for multiple sclerosis

2010-06-11T17:12:00.000-07:00

(Posted By: Josi Creek)

A Food and Drug Administration advisory panel on Thursday unanimously recommended approval of the first drug for multiple sclerosis (MS) that can be taken orally. Existing drugs for the disease have to be given intravenously or by injection. The new drug, targeted initially at relapsing-remitting MS, is called fingolimod and its manufacturer, Novartis, plans to use the brand name Gilenia. The agency is not required to follow the recommendations of its advisory panels, but it generally does.

"At last, we can treat a whole lot of MS people that we've not been able to treat before," Dr. Loren Rolak of the Marshfield Clinic in Wisconsin and a spokesman for the National MS Society, told CNN. That would include people who are afraid of needles, those who are resistant to existing drugs or are tired of their side effects and those who dislike the needle sticks.

MS is a disease in which the body's own immune system attacks the protective layer of myelin around nerve fibers, producing short circuits. Symptoms include visual disturbances, difficulty walking, fatigue, and loss of coordination, sensation, and bowel and bladder control. About 85% of the 400,000 Americans with the disease have the relapsing-remitting form, in which attacks on the body are followed by periods of remission -- although each relapse typically leaves the body more damaged.

Fingolimod works by preventing the release of the white blood cells that attack the myelin. That also leaves the user open to infections, however. Two studies reported in the New England Journal of Medicine in January showed that fingolimod reduced relapses by half. But the studies also showed that, at the highest dose used, 1.25 milligrams, the drug increased susceptibility to infections, cardiovascular effects, swelling of the retina and elevated levels of liver enzymes. The panel recommended approval of an 0.5-milligram dosage because it seems to have nearly the same benefits as the higher dose, but far fewer side effects. The panel also recommended that Novartis conduct a clinical trial using half that dose.

The FDA said the company would also be required to conduct a post-approval safety study to monitor for adverse effects of the drug.

The panel also recommended that the drug not be restricted to those who had failed other treatments, indicting it could be used as a first-line drug. To the disappointment of Novartis, however, the group also recommended that patients receiving the drug for the first time be monitored closely for six hours to watch for side effects. That might require them to stay in the physician's office for nearly a day.

Because the drug can be taken orally, some experts predict that it will be a blockbuster drug for Novartis, with annual sales of more than $1 billion.

Exercise Helps Multiple Sclerosis Patients

2010-06-11T11:01:00.000-07:00

(Posted By: Josi Creek)

Patients with multiple sclerosis (MS) are able to exercise longer when they take intermittent rest breaks, according to a new study presented here at the Consortium of Multiple Sclerosis Centers 24th Annual Conference and the Third Joint Meeting of Americas Committee for Treatment and Research in Multiple Sclerosis.

The approach could allow patients to get more benefit from exercise and physical therapy, researchers say.

Fatigue is a common symptom of MS and frequently limits a patient's ability to exercise. Herb Karpatkin, DSc, MPT, a physical therapist, MS specialist, and professor at the Hunter College Program in Physical Therapy in Brooklyn, New York, and colleagues set out to determine if patients reported different levels of fatigue when they engaged in intermittent instead of continuous exercise. They enrolled 30 ambulatory patients in a study with a repeated-measures, crossover, within-subject design. Participants had Expanded Disability Status Scale scores between 2.0 and 6.5. They were asked to perform 6 minutes of continuous or intermittent walking.

A visual analog scale of fatigue was used to measure fatigue. When patients walked for 6 minutes continuously, self-rating of fatigue went from a mean of 43.53 points to 68.73 points — an increase of 25.20 points. During intermittent walking, the mean fatigue score went from 48.03 to 57.20 — an increase of 9.17 points. Disease severity, duration, and the mood of the participant had no effect on the change in score.

The intermittent approach was suggested by his patients, Dr. Karpatkin told Medscape Neurology & Neurosurgery.

Intermittent exercise seems to have the same physical benefit as continuous exercise. A comparison hasn't been done in MS patients, but comparison studies of intermittent and continuous exercise have shown the 2 forms of exercise to be equivalent in chronic fatigue syndrome, diabetes, obesity, chronic obstructive pulmonary disease, and fibromyalgia, Dr. Karpatkin said.

Exercise does take longer, but success is generally its own reward, he noted. "There was 1 patient who couldn't walk more than 3 or 4 minutes on a treadmill; after a few sessions, she could do 20 or 25 minutes. That's a very powerful thing for her," Dr. Karpatkin said.

"It bodes well for us in how we prescribe exercise programs," Susan Bennett, PT, EdD, NCS, physical therapist and clinical associate professor at the University of Buffalo, New York, who attended the session, told MedscapeNeurology & Neurosurgery. Still, the results are preliminary. "More research is needed," Dr. Bennett added.

The study did not receive commercial support. Dr. Karpatkin and Dr. Bennett have disclosed no relevant financial relationships.

Vitamin D Linked to Poor Learning Performance in Patients With MS

2010-06-11T10:58:00.002-07:00

(Posted By: Josi Creek)

A new study shows that serum vitamin D deficiency is associated with poor learning performance among patients with multiple sclerosis (MS). The research was presented here at the Consortium of Multiple Sclerosis Centers 24th Annual Conference and the Third Joint Meeting of Americas Committee for Treatment and Research in Multiple Sclerosis.

There is some evidence that vitamin D suppresses proinflammatory cytokines, and that low levels of these cytokines could contribute to MS. Other evidence suggests that vitamin D plays a role in cognitive function in older adults. Cognitive impairment is very common in MS, but few studies have examined the relationship between serum vitamin D and cognitive deficits in this population.

The researchers enrolled 23 patients with relapsing-remitting MS and secondary progressive MS. After laboratory work to determine serum vitamin D levels, patients underwent a comprehensive neuropsychological evaluation to assess emotional functioning, memory, executive functioning, processing speed, attention, and visuospatial abilities.

Low vitamin D levels and poor performance were correlated on a verbal learning test (r = .49; P < .05). The effect was stronger in single-trial learning (r = .65; P < .001). No correlation was observed during later learning trials.

"These findings suggest the importance of determining vitamin D levels in order to maximize cognitive potential among MS patients. Future randomized trials should examine whether vitamin D supplementation may improve learning in MS," the researchers wrote in the abstract.

The work was prompted by several recent studies that showed a relationship between cognitive function and vitamin D levels in the elderly, Todd Feaster, PsyD, a neuropsychologist at the MidAmerica Neuroscience Institute in Lenexa, Kansas, told Medscape Neurology. Dr. Feaster also works with patients with Alzheimer's disease, so those findings struck a chord in him, he said.

The study suggests that cognitive impairment might not be caused by MS alone but could be caused or exacerbated by vitamin D deficiency, and supplementation might improve symptoms.

"When you have a winter like we've had in the Midwest, you're stuck inside all day. So is vitamin D deficiency exacerbating cognitive issues? And if we get those levels up, will we get improvement?" Dr. Feaster posited.

The study was relatively small, cautioned Helen Tremlett, PhD, assistant professor of neurology at the University of British Columbia in Vancouver, Canada. "It does need to be reproduced," she told Medscape Neurology.

"He didn't factor in seasonality, which could be [important]. But if the findings are true, we might be able to supplement vitamin D and bring up cognitive levels" in these patients, Dr. Tremlett suggested.

However, the study isn't robust enough to change clinical practice just yet. "We can't do an intervention based on what he's presented, but it gives us real food for thought. A longitudinal study would be nice to see," she remarked.

The study did not receive commercial support. Dr. Feaster and Dr. Tremlett have disclosed no relevant financial relationships.

Physical Therapy Improves Urinary Symptoms in Patients With Multiple Sclerosis

2010-06-11T10:56:00.000-07:00

(Posted By: Josi Creek)

A physical therapy regimen improves both urinary incontinence and urinary retention in patients with multiple sclerosis (MS), according to a study presented here at the Consortium of Multiple Sclerosis Centers 24th Annual Conference and the Third Joint Meeting of Americas Committee for Treatment and Research in Multiple Sclerosis.

Many patients with MS experience urinary dysfunction at some time during the disease course, which can have a significant effect on quality of life. Pharmacotherapy is available, but patients may choose against it because of adverse effects. As a result, Maria Lopes de Carvalho, MD, PhD, and colleagues from the Italian MS Society Rehabilitation Center in Genova, Italy, developed a physical therapy approach designed to improve symptoms of urinary dysfunction and conducted a study to test its effectiveness.

The investigators enrolled 62 patients (54 women, 8 men) with MS and urinary symptoms who had been referred for the first time to the rehabilitation center. Each patient was assigned an individualized rehabilitation program.

Mean age ± standard deviation was 52.67 ± 13.14 years. Mean time since disease onset was 13.78 ± 9.38 years. The patients had a mean Expanded Disability Status Scale score of 5.39 ± 1.39.

Dr. Lopes de Carvalho's team measured Expanded Disability Status Scale score, course and duration of disease, mobility status, symptoms (urgency, retention, hesitation, incontinence, frequency), postvoid residual volume on bladder ultrasound, Wagner Test of urinary incontinence, visual analogue scale, urodynamic investigation, pelvic floor muscle evaluation (Pubo-Coccygeal Grading Test and muscle coordination evaluation), and current pharmacologic therapies. Patients also completed a 5-day bladder diary.

On the basis of the information collected, the researchers developed an individualized urinary rehabilitation program. Mean duration of the program was 12 sessions.

At the end of the rehabilitation program, patients repeated the same evaluation conducted at baseline, without the urodynamic investigation. Primary outcomes included urinary incontinence (Wagner Test), mean number of episodes of leakage (bladder diary), mean number of episodes of urinary frequency in 5 days (bladder diary), nocturia and urgency, and urinary retention (postvoid residual). Secondary outcomes included change in visual analogue scale and Pubo-Coccygeal Grading Test.

At pretreatment, the mean Wagner Test score of urinary incontinence was 67.77. The mean score was 75.95 at the end of the rehabilitation program (P < .001).

Patients had a mean postvoid residual volume, measured with bladder ultrasound, of 113.39 mL at pretreatment and 97.93 mL at the end of the rehabilitation program (P = .010).

The rehabilitation effort was undertaken because "too many people were asking us to do something for their bladder and bowel problems," Dr. Lopes de Carvalho, who presented the study findings, told Medscape Neurology. "Everybody knows this is a big problem, but we have only pharmacological therapies," she added.

It was surprising that the team reported improvements in urinary retention, according to Ted Brown, MD, MPH, a physiatrist at the Multiple Sclerosis Center at Evergreen College in Kirkland, Washington. "People have looked at pelvic floor rehabilitation for urinary incontinence and bowel incontinence, but not retention. We've been concerned that if you strengthen the pelvic floor muscles, which is generally what we do with urinary incontinence, that it could make retention worse. [Dr. Lopes de Carvalho] showed you could actually help urinary retention with her techniques, which I found very interesting," Dr. Brown, who attended the session, told Medscape Neurology.

Dr. Brown noted that Dr. Lopes de Carvalho did not present specifics on the rehabilitation program. "It's novel. It would be interesting to learn how they came up with it."

The study did not receive commercial support. Dr. Lopes de Carvalho and Dr. Brown have disclosed no relevant financial relationships.

Vitamin D Exposure in Childhood Linked to Age at Onset of MS

2010-06-11T10:53:00.000-07:00

(Posted By: Josi Creek)

Levels of childhood sun exposure and the presence or absence of cod liver oil supplements predict age at onset of multiple sclerosis (MS), a new study suggests.

"There's been demonstrated to be a north–south gradient in multiple sclerosis incidence, and migrating later on in life, even after a diagnosis of MS, from a colder to a warmer climate, has been associated with an improvement in disease course," Walter Royal, III, MD, associate director for research at the Veterans Affairs MS Center of Excellence, East, Baltimore, MD, who presented the work here at the Consortium of Multiple Sclerosis Centers 24th Annual Conference and the Third Joint Meeting of Americas Committee for Treatment and Research in Multiple Sclerosis, told Medscape Neurology.

Vitamin D is known to affect immune system functions that appear to benefit MS and other autoimmune diseases. The new research further demonstrates that "early experience can have a lasting effect," Dr. Royal added.

Reduced MS Risk

Previous studies have shown that childhood sun exposure and cod liver oil supplements are associated with reduced risk of developing MS. In this report, the researchers examined a national cohort of veterans to determine whether these environmental factors affected the timing of symptom onset.

Participants were recruited from the nationally representative Veterans Health Administration Multiple Sclerosis Surveillance Registry, which includes age at MS symptom onset, disease subtype, home address location history, sun exposure, and intake of high vitamin D–content foods. All information was available by 5-year increments.

For each participant, the researchers estimated past sun exposures for fall/winter and spring/summer seasons. They used latitude, altitude, and ultraviolet radiation count of the reported home residences to estimate solar radiation exposure. Multiple regression analysis was then used to link these variables to age at MS onset. The study included 948 patients with relapsing MS.

For those living in low– to medium–solar radiation areas, the researchers found a significant association between earlier age at onset of symptoms and sun exposure in the fall/winter season between the ages of 6 and 15 years (2.3 years average earlier onset; P = .01). Intake of cod liver oil during childhood produced a 3-year delay in onset (P = .01).

Vitamin D levels are frequently low in patients with MS, and physicians often prescribe supplements. The results of this study imply that such the strategy should be successful in changing the course of the disease, and that children of patients with MS should receive vitamin D supplements, according to Dr. Royal.

Time in the Sun

However, given the concerns today about sun exposure, many children are encouraged to spend less time in the sun, or to wear skin protection when they do. MS also has a relatively low family incidence, so identifying at-risk children is difficult, according to James Simsarian, MD, director of the Multiple Sclerosis Program at the Neurology Center of Fairfax, Virginia, who attended the session here.

"We've always talked about environmental factors at play [in developing MS], and [vitamin D exposure] could be one of them," Dr. Simsarian told Medscape Neurology.

The study did not receive commercial support. Dr. Prieto and Dr. Schapiro have disclosed no relevant financial relationships.

New Multiple Sclerosis Drug , Fingolimod, Expected to be Approved by FDA

2010-06-10T15:25:00.000-07:00

(Posted By: Josi Creek)

The panel that recommends drug approvals to the FDA has unanimously agreed that the multiple sclerosis drug, fingolimod is safe and effective. The panel is comprised of 25 medical experts not employed by the FDA. The proposed drug is manufactured by the Swiss company Novartis and would be marketed under the name Gilenia. If approved, the drug is expected to bring in more than one billion dollar in annual sales for the company.

The panel recommends another study be completed that involves a lower dosage amount but does not feel approval should wait on those results. The current dosage is being recommended at 0.5 milligrams. The panel voted for studies to be completed with a dosage of .25 milligrams to determine the drug’s effectiveness at a lower, safer dosage. Novartis explains the new studies would take at least five to six years to complete. The FDA requires new drugs to have post approval studies completed as well. Those studies would include patients who suffer from other ailments along with MS and determine if the drug side effects are more prevalent in those groups.

Some of the side effects associated with Gilenia include a low heart rate, a slight decrease in lung function, and macular edema, an eye problem. The drug is designed to delay the debilitating effects of MS. Novartis is hoping to get their drug approved before their competitor Merck reveals its own version of an MS drug. The FDA typically follows the recommendations of the advisory board. They are expected to make a final approval decision by September.

Vitamin D Linked to Poor Learning Performance in Patients With Multiple Sclerosis

2010-06-09T15:21:00.000-07:00

(Posted By: Josi Creek)

A new study shows that serum vitamin D deficiency is associated with poor learning performance among patients with multiple sclerosis (MS). The research was presented here at the Consortium of Multiple Sclerosis Centers 24th Annual Conference and the Third Joint Meeting of Americas Committee for Treatment and Research in Multiple Sclerosis.

The study suggests that cognitive impairment might not be caused by MS alone but could be caused or exacerbated by vitamin D deficiency, and supplementation might improve symptoms.

The study did not receive commercial support. Dr. Feaster and Dr. Tremlett have disclosed no relevant financial relationships.

New Adult Stem-Cell Treatments Advance

2010-06-09T11:03:00.000-07:00

(Posted By: Josi Creek)

New reports indicate that real hope for ‘miracle’ treatments using adult stem cells is on the way for those suffering from diseases afflicting both the brain and the heart.

New reports indicate that real hope for ‘miracle’ treatments using adult stem cells is on the way for those suffering from diseases afflicting both the brain and the heart.

In California, researchers at the University of California in Irvine say they have discovered the method and mechanisms by which adult stem-cells can repair and replace damaged tissue in the brain. The discovery could lead to treatments for individuals with multiple sclerosis and other brain inflammation diseases.

“Previously, we’ve seen that adult neural stem cells injected into the spinal column knew, amazingly, exactly where to go,” said Tom Lane, a professor of molecular biology and biochemistry, and co-author with Kevin Carbajal of the new study. “We wanted to find what directed them to the right injury spots.”

Lane and Carbajal’s team experimented with mice whose central nervous systems were damaged by viruses in a way that imitated the effects of MS. The virus destroys myelin, a protective tissue that covers the nerves, resulting in chronic pain and loss of motor function.

They injected adult neural stem cells into the mice and observed that the inflamed cells activated receptors on the adult stem cells called CXCR-4 receptors. These receptors then gathered “chemokine proteins” (CXCL-12), which guided the adult stem cells to the damaged cells in need of repair.

As the adult stem cells made their journey through the brain, they transformed into precursor cells for oligodendrocytes, a key building block for myelin, that can both repair or replace the damaged tissues. Once latched onto the affected sites, the stem cells continued to differentiate, and after three weeks 90% of the cells had transformed into mature oligodendrocytes.

Lane stressed that not only did the work reaffirm the power of adult neural stem cells to improve the brain’s motor function, but also provided a crucial stem cell roadmap for researchers looking to develop therapies for those suffering with MS.

“In this study, we’ve taken an important step by showing the navigational cues in an inflammatory environment like MS that guide stem cells,” explained Lane. “Hopefully, these cues can be incorporated into stem cell-based treatments to enhance their ability to repair injury.”

While advances have been made in treating the diseases of the head, a young girl is undergoing an experimental adult stem cell treatment that, if successful, would finally allow her to overcome a rare disease of the heart called Eisenmenger syndrome.

The News Tribune reports that Washington State resident Mailia Goforth, 16, has suffered from the disease since birth. The condition is caused by a structural defect in the heart, where blood flows through a hole in the heart wall. Additionally she suffers from secondary pulmonary hypertension because too much blood flows to her lungs; the blood vessels then constrict, putting even more strain on the heart. In Mailia’s case, doctors identified her condition too late for normal surgical repair or even the more drastic measure of a double lung and heart replacement.

The teenager, however, is being treated in the Dominican Republic with stem cells derived from her own blood, which are injected into her lungs via a small catheter. If successful, the therapy – developed by Dr. Zannos Grekos, MD – would significantly reduce the pressure on Mailia’s heart, and enable her to breathe freely. It would also theoretically allow surgeons to repair her heart.

The treatment has so far cost Mailia’s parents $64,000. Forty-seven thousand of that amount was raised by the parents, with the rest being covered by a private charity. The family, however, expects that Mailia will need a second round of stem cell treatments in addition to the surgeries, which Grekos speculated to the Tribune could enable her to play sports one day.

Novartis’ Multiple Sclerosis Pill, Gilenia, Faces FDA Review

2010-06-08T06:54:00.000-07:00

(Posted By: Josi Creek)

Novartis AG’s drug Gilenia has risks that may outweigh its benefit in treating multiple sclerosis, according to U.S. regulators reviewing whether to approve the first pill to slow progression of the disease.

Gilenia, while effective, causes a gradual decline in lung function and is linked to certain cancers, Food and Drug Administration staff said in a review today. Outside advisers to the FDA will meet June 10 to recommend whether the drug, also called fingolimod, should be approved for sale.

Novartis, of Basel, Switzerland, is racing German drugmaker Merck KGaA to sell the first pill to stall MS, competing with injected remedies led by Biogen Idec Inc.’s Avonex. The FDA has said it will complete its review by September. Gilenia may go on sale in 2010 and reap $1 billion a year, Novartis has said.

“The pivotal efficacy studies provide robust evidence of the efficacy of fingolimod to reduce the frequency of clinical exacerbations in patients with relapsing remitting MS,” FDA staff said in the report. “The clinical development program also uncovered a number of safety issues, which will be the primary focus for the advisory committee meeting.”

Skin cancer and heart risks will probably fuel a “vigorous debate” at the panel meeting, Yaron Werber, an analyst for Citibank in New York, said June 4 in a research note. Those risks were linked to the treatment in a study published in January in the New England Journal of Medicine, and also identified as adverse events in the FDA review today.

Postpartum Steroids Reduce Multiple Sclerosis Relapses

2010-06-07T15:15:00.000-07:00

(Posted By: Josi Creek)

A single dose of methylprednisolone given to new mothers with multiple sclerosis immediately after delivery reduced the risk of relapse for up to three months, researchers found.

During the first postpartum trimester, relapses occurred in 18% of new mothers who received 1 g of intravenous methylprednisolone compared with 46% of those not receiving treatment (P=0.0448), according to data presented here at the meeting of the Joint Consortium of Multiple Sclerosis Centers and America's Committee on Treatment and Research in Multiple Sclerosis.

In the following six months, there was no difference in the relapse rates between the two groups, Jose Avila, MD, of the Maxine Mesinger MS Comprehensive Clinic at Baylor College of Medicine in Houston, reported.

Preliminary work from other centers has suggested that IV methylprednisolone might be effective in reducing the relapse rate after birth. Avila's group had been using this treatment in many new mothers at their clinic and so performed a retrospective analysis of their outcomes to further understand its potential.

The researchers examined 50 patients with relapsing-remitting MS and two with primary progressive disease. Of those, 39 had received steroid treatment immediately after giving birth, and 13 had not. The mean ages of the women were the same in each group, as was the mean disability score. Both groups had similar relapse rates in the year before pregnancy, and each group contained one patient with the primary progressive form of the disease.

The results of the trial suggest that IV methylprednisolone immediately postpartum may be an important treatment option for women with MS, Avila said, although larger and prospective trials are needed first.

He also indicated that a second dose of methylprednisolone may be worth investigating, to determine if it can reduce relapse rate later into the postpartum period.

Biogen’s CEO Retires Tomorrow

2010-06-07T15:10:00.000-07:00

(Posted By: Josi Creek)

Biogen Idec will officially be CEO-less starting tomorrow. James Mullen, Biogen’s chief executive, retires on June 8 after a decade on the job and the Cambridge, MA-based company hasn’t named his successor.

The company, which also has significant operations in San Diego, said this afternoon that its in the final stages of selecting the firm’s future head honcho and expects to reveal its choice in “the coming weeks.” Whether the company, the world’s largest maker of drugs for multiple sclerosis, has even made an offer or picked someone for the CEO post is unclear. Biogen spokeswoman Christina Chan declined to comment on these specifics today.
In the meantime, the firm said today that the company’s chief operating officer, Robert Hamm, is retiring from the company on Dec. 31, 2010 after 16 years at the company.
Biogen’s search for a new chief executive began around the time Mullen announced his retirement from the CEO post and the firm’s board on January 4. Mullen, who became CEO of Biogen in 2000, has taken some shots from billionaire investor Carl Icahn in recent years for the company’s poor stock performance compared with its peers in the biotech sector. Icahn also has blasted Biogen’s senior management for the company’s inability to launch a new drug on the U.S. market since the FDA approved its hit MS product natalizumab (Tysabri) in November 2004.
Until Mullen’s successor is named, the company’s senior executives will report to the firm’s chairman, William Young. Young talked to Xconomy in February about the company’s high-profile CEO search, saying that Biogen may opt to hire a scientist for the firm’s No. 1 job.

Simple eye test measures damage from multiple sclerosis

2010-06-07T15:04:00.000-07:00

(Posted By: Josi Creek)

A quick, painless eye measurement shows promise as a way to diagnose multiple sclerosis in its very early stages, and to track the effectiveness of treatments, researchers from UT Southwestern Medical Center have found in a multicenter study. "This technique has the potential to provide a powerful and reliable assessment strategy to measure structural changes in the central nervous system, both for diagnostic purposes and in clinical trials to monitor whether potential treatments can prevent deterioration or restore nerve function," said Dr. Elliot Frohman, professor of neurology and ophthalmology, director of the Multiple Sclerosis Clinical Center at UT Southwestern and co-senior author of the study, which appears in the June issue of Annals of Neurology.

The technique, called optical coherence tomography (OCT), reliably measures thinning of the retina in people with multiple sclerosis, the researchers found.

"An ophthalmologist might someday be able to use OCT to identify retinal thinning during a routine eye exam and consider MS as a prime diagnosis," Dr. Frohman said. "However, this prospect is a long way off."

The retina, which lines the back of the eye, detects light and sends visual information to the brain via the optic nerve. Retinal thinning can occur as a result of multiple sclerosis, but this study, Dr. Frohman said, is the first to track such thinning over time in a single group of patients. The Neurology study involved 299 patients with MS who were tracked for six months to 4.5 years.

The researchers found that the retinas thinned significantly with time, and patients often concurrently lost visual sharpness. Overall, the study indicated that OCT is reliable, easy to use and sensitive to changes over time. It could also be used with current clinical measures, the researchers said.

Because the retina is easily visible through the pupil, it provides a convenient route for assessing nerve damage, compared with other parts of the body. As a result, retinal measurement might be able to pick up signs of multiple sclerosis before a person develops other symptoms, Dr. Frohman said.

OCT machines already are available. Patients look into a device similar to those that measure vision for corrective lenses. Near-infrared light, which is invisible to the eye, penetrates the retina and provides information on its thickness. The measurement takes a few seconds for each eye.

In addition to the OCT testing, patients in the latest study looked at eye charts so the researchers could test their vision. Control subjects came from the patients' families and clinics' staff.

Future studies are needed to ascertain whether OCT can characterize the effectiveness of treatments, Dr. Frohman said.

Costa Rica clamps down on dodgy stem cell treatments

2010-06-07T10:14:00.000-07:00

(Posted By: Josi Creek)

Costa Rica has put an end to stem cell tourism, saying there's no evidence that the treatments work or are even safe.

Using stem cells from bone marrow, umbilical cords and other sources, Costa Rican clinics have been claiming to offer cures for injuries and degenerative diseases.
There is little - if any - evidence that these treatments work, and they have not been approved by the Federal Drug Administration (FDA).
But the Costa Rican Health Ministry has now closed down the country's largest stem cell treatment clinic. The Institute of Cellular Medicine claims to have treated about 400 patients, mostly from the US, for conditions including multiple sclerosis, arthritis and spinal injuries.
Patients paid up to $30,000 for treatment.
While adult stem cells are a proven treatment for a small number of blood and immune system disorders, there's no evidence that they affect these conditions which the clinic was claiming to treat.
"If [stem cell treatment's] efficiency and safety has not been proven, we don't believe it should be used," Dr Ileana Herrera, chief of the ministry's research council, told Reuter. "As a health ministry, we must always protect the human being."
Similar clinics operate in many other countries, including Thailand, China and Russia.

Multiple sclerosis patients who took oral fingolimod showed better results than those treated with injected interferon beta-1A,

2010-06-07T10:04:00.000-07:00

(Posted By: Josi Creek)

Multiple sclerosis patients who took the oral investigational agent fingolimod were better able to maintain activities of daily living over a year than those treated with injected interferon beta-1A, according to a study presented here.

Patients taking the standard injected therapy interferon beta-1A (Avonex) had more pronounced decline in their ability to perform ADLs based on a patient reported activity scale -- dropping by 0.43 points over 12 months, compared with those on either of two doses of fingolimod, whose scores dropped by just 0.08 and 0.12 points (P<0.05 for both comparisons), Jeffrey Cohen, MD, of the Neurologic Institute of the Cleveland Clinic in Cleveland, Ohio, reported.

Fingolimod has previously been shown to reduce multiple objective measures of disease activity in patients with relapsing-remitting MS, as part of the TRANSFORMS study, which compared fingolimod to interferon beta-1A, Cohen said here at the meeting of the Joint Consortium of Multiple Sclerosis Centers and America's Committee on Treatment and Research in Multiple Sclerosis.

The current study is a tertiary analysis from that study.

Fingolimod modulates sphingosine-1-phosphate receptors on lymphocytes, blocking their exit from the lymph node, and thus reducing self-reactive lymphocytes in the central nervous system, Cohen explained.

Patients in the study were randomized to receive daily oral fingolimod at either 0.125 mg or 0.5 mg, or 30 μ of intramuscular interferon beta-1a, for 12 months.

All patients concurrently received a placebo treatment matching the other treatment arm. The three treatment groups were matched for mean age (36 years), disease duration (mean seven years), recent relapses, and disability.

The effect of treatment on activities of daily living was measured with the PRIMUS scale, a patient self-reported measure developed with patient input.

The scale comprises 15 items covering numerous domains, such as ability to do light jobs around the house, climb a flight of stairs, or prepare food, and has been validated for use in clinical trials. Each question is scored either 0 (no limitations), 1 (activity performed with difficulty), or 2 (cannot perform the activity), for a minimum score of 0 and a maximum of 30.

The scale was administered at baseline, six months, and 12 months. Because the scale was not available in the language of all participating countries, only 909 of the 1,292 patients in the TRANSFORMS study participated, and 832 completed the 12-month evaluation.

Baseline PRIMUS scores were "overall quite low," Cohen said, with mean scores of 3.2, 3.2, and 3.0, in the low-dose fingolimod, high-dose fingolimod, and in the interferon groups, respectively.

Low-and high-dose fingolimod were superior to interferon beta-1A not only in total change from baseline, but also in the percentage of patients who improved on the PRIMUS scale during the 12 months (17.5%, 19.5%, and 14.1% respectively), and the percent who worsened (17.9%, 19.6%, and 24.1%, respectively).

But, Cohen noted, the baseline disability of the patients was "quite mild," and "the overall magnitude of mean change was quite small in all three groups."

"The trial was of relatively short duration, and a longer follow-up will be needed to obtain more clinically meaningful results," he said.

Rock Heyman, MD, of the Department of Neurology at the University of Pittsburgh School of Medicine, commented that a quality-of-life scale is valuable in MS.

The standard measures of MS progression, including even relapse rates, "may mean a lot to neurologists," he said, "but may not mean as much to patients," who are likely more interested in those aspects directly measured by quality-of-life scales.

The results on the PRIMUS scale in this trial indicate the medicine "is helping to preserve day-to-day function," he continued. "Patients want to see everything else as well, but they want to know, 'how am I going to feel after a year?'"

Heyman did not recommend that quality-of-life measures be the major outcome of trials, since they do not directly measure disease modification, "but they are very important and should be taken into account."

An FDA advisory panel is meeting on Thursday to decide whether to recommend fingolimod for approval.

Bayer launches iPhone app to help people manage their multiple sclerosis treatment

2010-06-06T13:53:00.000-07:00

(Posted By: Josi Creek)

This application was unveiled as part of Bayer’s patient support program, BETAPLUS, and it provides patients with injection reminders, injection site rotation assistance and injection history for BETASERON. Moreover, through the Internet, myBETAapp also gives patients access to the BETAPLUS web page from where users can access links to educational tools and get peer support. Patients enrolled in the BETAPLUS program can dial directly to speak to BETA Nurses, who are specially trained in MS.

Investigational Oral Disease Modifying Drug Showing Improved Outcomes For Multiple Sclerosis patients

2010-06-05T12:29:00.000-07:00

(Posted By: Josi Creek)

Teriflunomide in Adjunct to Interferon Beta Significantly Improved Outcomes of Multiple Sclerosis Patients

Sanofi-aventis reported today new one-year data from a Phase II study with teriflunomide, a novel oral disease modifier being investigated for the treatment of relapsing multiple sclerosis (RMS). Study results demonstrated an improvement in outcomes, with a consistent safety profile with the data from a previous Phase II monotherapy study, in patients treated with interferon beta (IFN-[BETA]) - a standard therapy in RMS - and receiving teriflunomide 7mg or 14mg, compared with patients treated with IFN-[BETA] and receiving oral placebo.

The findings were the subject of the leading oral presentation at the American Committee for Treatment and Research in Multiple Sclerosis meeting (ACTRIMS) in San Antonio, TX, USA. This study is part of a comprehensive clinical development program for teriflunomide both in monotherapy and in adjunct therapy in MS patients.

Although this Phase II study (n=116) was not powered to test for efficacy, patients taking 7mg or 14mg teriflunomide in adjunct to stable dose IFN-[BETA] experienced a significant relative risk reduction (86%; p=0.0005 and 82.8%; p<0.0001 respectively) in the number of gadolinium enhancing T1 (T1-Gd) lesions on brain magnetic resonance imaging compared with patients taking stable dose IFN-[BETA] with placebo. No unexpected safety findings have been showed with teriflunomide during the one-year period of the study as compared to the initial six-month period. Discontinuations due to treatment-emergent adverse events (TEAEs) were low and numerically similar in the three groups (placebo: 2; 7mg: 3; 14mg: 3).

"These full-year exploratory study results are encouraging as they demonstrate significant improvement in disease activity based on MRI and an acceptable safety profile associated with teriflunomide when added on top of stable therapy with IFN-[BETA]," said Mark S. Freedman, HBSc, MSc, M.D., Professor of Neurology, Department of Medicine, University of Ottawa, Ontario, Canada. "Adjunct therapy could fill an unmet medical need for those patients who are on interferon therapy but have some disease activity as measured by MRI or relapse rate. We hope to replicate the results in a Phase III study program."

A dose-dependent trend toward a relative risk reduction in the volume of brain lesions was observed with teriflunomide 7mg or 14 mg groups when used as adjunct therapy compared with placebo (72.1%; p=0.11 and 70.6%; p=0.01 respectively). There was also a dose-dependent trend to a reduction in annualized relapse rate of 32.6% (p=0.43) and 57.9% (p=0.11) in 7mg or 14mg teriflunomide adjunct groups respectively compared to IFN-[BETA] with placebo.

The most frequently reported treatment emergent adverse events were upper respiratory tract infections as a whole (placebo: 17.1%; 7mg: 16.2%; 14mg: 23.7%), mainly nasopharyngitis and sinusitis, all types of headaches (placebo: 7.3%; 7mg: 5.4%; 14mg: 18.4%), all gastrointestinal disorders (placebo: 24.4%; 7mg: 18.9%; 14mg: 31.6%). White blood cell counts decreases were numerically comparable in both teriflunomide and placebo treatment groups (placebo: 3; 7mg: 3; 14mg: 4) and no patients discontinued treatment due to neutropenia or infection. Hepatic TEAEs were mainly asymptomatic liver enzyme elevation; mostly alanine aminotransferase (ALT) increased, not exceeding three times the upper limit of the norm and no cases of concurrent increase of ALT and total bilirubine were reported.

About teriflunomide

Teriflunomide is a new oral disease modifier that blocks de novo pyrimidine synthesis thus reducing T- and B-cells proliferation with no cytotoxicity. A comprehensive clinical development program for teriflunomide has been launched in monotherapy (Phase III studies are ongoing) and in adjunct therapy (Phase II studies are closed). This Phase II study with once daily oral teriflunomide on top of IFN-[BETA] was a multicenter, placebo-controlled, double-blinded, randomized study, conducted in relapsing multiple sclerosis patients. The primary objective of the study was to evaluate the tolerability and safety of teriflunomide 7mg and 14mg in adjunct therapy with IFN-[BETA]. The one-year results of this study presented this year during the ACTRIMS congress complement the 24-weeks study results presented last year at the European Committee for Treatment and Research in Multiple Sclerosis congress (ECTRIMS). Results from a second Phase II study with teriflunomide in adjunct therapy with glatiramer acetate (GA) compared with matching placebo added to GA, were also presented this year during the American Academy of Neurology (AAN) meeting.

Safety fears hang over pioneering Novartis Multiple Sclerosis pill

2010-06-04T14:00:00.000-07:00

(Posted By: Josi Creek)

"In clinical trials Gilenia has been linked to a range of worrying side effects, including skin cancer, heart problems and infections."

Swiss drugmaker Novartis AG's race to get the first multiple sclerosis pill to market reaches a pivotal point next week when U.S. experts vote on whether Gilenia should be recommended for approval.

A green light is far from assured. Although the new drug has outperformed current injectable medicines in trials, it is associated with a range of potentially serious side effects that could limit its use or block it from the market altogether.

Industry analysts at Citigroup think the safety issues on Gilenia are a "50/50 call" and the market generally is cautious, suggesting scope for significant share price moves depending on the outcome of the June 10 advisory meeting.

Novartis officials, however, are hopeful the experts will see a positive risk-reward balance for the medicine, especially now that a lower dose is being used, which has reduced the frequency of side effects.

If it is successful, Gilenia -- which Novartis licensed from Mitsubishi Tanabe Pharma Corp (4508.T) -- could win a sizable chunk of existing multiple sclerosis (MS) drug sales, totalling some $10 billion a year, and expand the overall market.

With its potential to help Novartis overcome patent losses on older drugs, the decision on Gilenia is seen by analysts as a key news event for the group this year.

The drug has a clear advantage in being easier to take than injectables from Biogen Idec Inc , Bayer AG, Merck and Teva Pharmaceutical Industries Ltd , as well as not causing the flu-like symptoms seen with some of these products.

But in clinical trials Gilenia has been linked to a range of worrying side effects, including skin cancer, heart problems and infections. These are expected to dominate when Food and Drug Administration (FDA) staff publish briefing documents on the medicine ahead of the panel meeting on June 8.

BILLIONS OF DOLLARS

Jeffrey Holford and colleagues at brokerage Jefferies think these issues are manageable -- especially given the lower dose of the drug now being used -- and predict Gilenia will generate peak annual sales of $3.5 billion, with $1.6 billion by 2014.

Nomura forecasts an even faster ramp-up, to $2.1 billion by 2014. But the overall view is more cautious, with consensus forecasts pointing to sales of $987 million by 2014, according to Thomson Reuters data.

Hovering in many investors' minds is the recent history of Biogen and Elan Corp's (ELN.I) Tysabri, an antibody drug for MS whose sales potential has been severely cut by side effects and a restrictive surveillance programme.

Gilenia's fate will be watched closely by rivals with competing MS pills a year or two behind in development.

They include laquinimod from Teva, teriflunomide from Sanofi-Aventis SA (SASY.PA) and BG-12 from Biogen -- as well as Mylinax from Germany's Merck, which initially looked ahead of Gilenia in the race until a rebuff from the FDA last November. [ID:nGEE5AT1KS]

The FDA, which doesn't always follow the advice of its advisory committees, is due to give its verdict on Gilenia by September.

In Europe, a decision is expected from regulators around the end of the year or early in 2011.

Developing new drugs for MS is an innately tricky business because treatment centres on dampening the body's immune system, which increases the risk of other health problems.

MS disrupts the way in which nerve impulses are carried to and from the brain and can cause permanent disability. Symptoms may include numbness or weakness in one or more limbs, partial or complete loss of vision, tingling or pain and tremors.

New Formulation of Copaxone:Teva Announces Positive Study Results

2010-06-04T13:52:00.000-07:00

(Posted By: Josi Creek)

Significantly less pain and fewer injection site reactions were reported by patients receiving the new lower volume injection

Teva Pharmaceutical Industries Ltd. today announced positive results from a study assessing a new lower-volume injection of Copaxone(R) (glatiramer acetate) containing the currently approved dose in half the injection volume.
The SONG study ('Study of New Glatiramer Acetate Formulation') explored the safety and tolerability of a 20mg/0.5mL injection of Copaxone(R) versus the current formulation of 20 mg/1.0mL.
These findings were presented at the 24th Annual meeting of the Consortium of Multiple Sclerosis Centers (CMSC) in San Antonio, Texas.
"Copaxone(R) has proven long-term efficacy, safety and tolerability with more than one million patient years of treatment," said Dr. Ronald Murray, FAAN, a lead study investigator and Director of the MS Clinic of Colorado. "We are encouraged by these data as they suggest that a 0.5mL dose of glatiramer acetate may enhance patients' experience with the most frequently prescribed MS therapy."
The SONG study enrolled 148 relapsing-remitting MS patients (RRMS) at 21 sites in the United States. Data demonstrated that both the 1.0mL and 0.5mL products were safe and well tolerated. Patients receiving the lower-volume injection reported significantly less pain immediately following and five minutes after administration (p<0.0001). Although the presence of injection site reactions (swelling, redness, itching, lumps) was not high for either group, patients reported fewer and less severe reactions within five minutes (p<0.0001) and 24 hours (p<0.0001) post-administration with the 20mg/0.5mL product. No serious adverse events were reported in the study.
"Copaxone(R) is the global market leading RRMS treatment, and Teva is continuously pursuing research focused on further enhancing the patient treatment experience with the product," said Moshe Manor, Teva's Group Vice President, Global Branded Products. "Our investment in research has already translated to increased benefits for Copaxone(R) patients, including an expanded indication to treat early-stage MS-like symptoms in patients at risk of progression to an MS diagnosis, as well as device improvements such as a thinner needle to reduce injection discomfort and an auto inject device to better facilitate treatment delivery."

Stem Cell Therapies for Multiple Sclerosis Now Possible

2010-06-02T07:25:00.000-07:00

(Posted By: Josi Creek)

A team of investigators from the University of California in Irvine (UCI) Sue & Bill Gross Stem Cell Research Center have recently made important strides in the field of using stem cells as therapies for mitigating the effects of injuries on the central nervous systems. The investigators managed to discover the mechanisms employed by adult neural stem cells, as they navigate through the human brain to the site of injuries, in order to fix the damages. This is the final piece to a puzzle that, once completely solved, could allow researchers to create new, stem cell-based therapies for inflammatory diseases of the brain, such as, for instance, multiple sclerosis (MS).

According to Center investigators Tom Lane and Kevin Carbajal, the leaders of the research effort, the answer to the riddle laid within the actions of the immune system. Details of their study appear in this week's early online issue of the esteemed scientific publication Proceedings of the National Academy of Sciences (PNAS). The experts believe that the new knowledge, which also includes details about how transplanted stem cells get targeted to the location where they are needed, could help inform bioengineers in developing new stem cell therapies aimed directly at neurological diseases whose main trait is inflammation. Multiple sclerosis is the most notorious example in this sense.

“Previously, we’ve seen that adult neural stem cells injected into the spinal column knew, amazingly, exactly where to go. We wanted to find what directed them to the right injury spots,” says Lane, who is also the Chancellor’s Fellow, and a UCI professor of molecular biology & biochemistry. “In this study, we’ve taken an important step by showing the navigational cues in an inflammatory environment like MS that guide stem cells. Hopefully, these cues can be incorporated into stem cell-based treatments to enhance their ability to repair injury,” the expert adds.

In previous studies that Lane and his team conducted, it was demonstrated that therapies based on adult neural stem cells were able to improve motor functions in mice with chronic MS symptoms. This is why the group believes that the new work could have far-reaching implications for human patients as well. Given the new knowledge, it may be safe to hypothesize that using adult stem cells, and knowing how to target them to where they need to go, may help human MS patients as well. Lane is the recent recipient of a Collaborative MS Research Center Award from the National Multiple Sclerosis Society

Study: Epstein-Barr virus antibodies in serum and cerebrospinal fluid from Multiple sclerosis, Chronic Inflammatory Demyelinating Polyradiculoneuropathy and Amyotrophic Lateral Sclerosis.

2010-06-01T17:18:00.002-07:00

(Posted By: Josi Creek)

Glatiramer acetate recovers microscopic tissue damage in patients with multiple sclerosis

2010-06-01T17:17:00.000-07:00

(Posted By: Josi Creek)

Traditional magnetic resonance imaging (MRI) techniques have contributed to the management of multiple sclerosis (MS) but are limited in their ability to detect neuronal damage. Advanced MRI metrics provide assessment of microscopic neuronal changes; however, few studies have examined the effects of MS therapies on these measures.

A Study On Imaging of Spinal Cord Lesions

2010-06-01T17:15:00.001-07:00

(Posted By: Josi Creek)

Study: Changes in Multiple Sclerosis Brain as shown on MRI

2010-06-01T17:11:00.000-07:00

(Posted By: Josi Creek)

VIDEO: Ampyra helps MS patients to walk again

2010-05-29T10:57:00.000-07:00

(Posted By: Josi Creek)

German pharma makes progress in new drugs to treat multiple sclerosis

2010-05-28T07:33:00.000-07:00

(Posted By: Josi Creek)

“Multiple sclerosis patients can look forward to significant improvements in the treatment of the disease,” said Cornelia Yzer, general manager of the VFA, the German research-based pharmaceutical industry association. Ms Yzer’s speech marked this week’s World Multiple Sclerosis Day.

“Pharma groups are developing no fewer than four new compounds to prevent relapses. These could be taken in tablet form, thus replacing the regular injections that have hitherto been necessary. These compounds could even be more effective at preventing relapses than the ones in use now,” noted Ms Yzer.

Around 130,000 people in Germany and over 2 million worldwide suffer from MS, which damages and interferes with the nervous system. It scrambles messages between the brain and other parts of the body. For most patients, the disease is characterized by periods of relapse and remission, with symptoms ranging from blurred vision to weak limbs subsiding and largely disappearing for a time after attacking a patient. The drugs currently available temper acute symptoms and reduce the risk of remission by around a third.
Two drug approvals anticipated by end 2013
Even though therapy for many patients could become simpler and more effective with the new tablets, further drugs requiring injections or infusions are also being developed and tested. That is because these drugs, which are designed to tackle certain kinds of cells, could prove especially effective in preventing remission for some patients. Two such drugs could be approved by the end of 2013. Also in the approval pipeline are two drugs to alleviate the symptoms of advanced MS. One is designed to improve patients’ ability to walk and the other to tackle spasms.
“Half of Germany’s pharma companies are working on new drugs against neurological diseases such as MS. The companies will not rest until this disease becomes readily treatable and patients no longer have to worry about having a disability,” Ms Yzer concluded.

Lifetime cost of multiple sclerosis: $1.2 million per patient

2010-05-27T07:15:00.000-07:00

(Posted By: Josi Creek)

In honor of World MS Day, the Multiple Sclerosis International Federation has released a report on the economic impact of the disabling autoimmune disease. Based on data from 15 countries, the report shows the average lifetime cost of MS is $1.2 million per patient - and "loss of employment, or early retirement, is considered the single largest cost factor contributing to this financial cost."

Indeed, 67 percent of respondents of a separate, Web-based survey said their disease had affected their work; patients either stopped working, reduced their hours, or changed their occupation. (Fatigue and mobility related problems were cited as two common factors preventing people from working.)

As reported by WebMD, the MS organization argues these findings emphasize "the need of a concerted global effort to help people stay on the job:"

"The cost to society of losing these people permanently from the workforce is enormous," Peer Baneke, chief executive officer of MSIF, says in the news release. "There needs to be greater awareness that a diagnosis of MS does not have to mean a lifetime without work. People with MS around the world continue to work and contribute to society, but this requires some flexibility on the part of employers and support from governments."

Biogen Idec Globally Commemorates Annual World MS Day

2010-05-27T07:10:00.000-07:00

(Posted By: Josi Creek)

On May 26, Biogen Idec will join the global multiple sclerosis (MS) community to commemorate the second annual World MS Day. Biogen Idec is a leader in the fight against MS, bringing hope to the thousands of patients across the globe who benefit from the company's MS therapies and ongoing research programs.

World MS Day was established by the Multiple Sclerosis International Federation to raise awareness of MS, national MS societies and those living with and affected by MS, to unite, broaden and mobilize the community and to support MS-directed fundraising. This year's World MS Day focuses on raising awareness of employment issues amongst those who are living with MS.

No company is doing more for people living with MS, and to support World MS Day, Biogen Idec will be sponsoring a number of events across the globe. Highlights include:

-- In the United States, conducting a MyMS Yoga class for MS patients with world-renowned yoga instructor Baron Baptiste and teaming up with O'Jays singer Walter Williams as he shares his experiences about living with MS;

-- In France, hosting an art exhibit with paintings from MS patients and partnering with local MS societies for the opening of the "House of MS" where patients and their families can go to learn more about MS and discuss living with their disease with physicians, psychologists, nurses and patient associations;

-- In Germany, along with a local patient organization, hosting "Multiple Sclerosis: A Subject, that Concerns Us All," an MS awareness event with a climbing wall, artists, musicians and MS information booths;

-- In Switzerland, providing yoga lessons to raise awareness of MS as part of the MS Yoga program;

-- In Ireland, asking people to encourage employers to support people with MS in the workplace through a call to action;

-- In Japan, distributing information about MS to the public to raise awareness of the disease; and

-- In India, supporting chapters of a local patient organization through MS-educational events.

"Biogen Idec is committed to bringing hope to the MS community by developing more effective and convenient therapies for those living with MS," said John R. Richert, M.D., vice president and senior fellow, Neurology Research and Development, Biogen Idec. "Part of this effort is to set new standards to measure success and to redefine future success in MS treatment. As we continue to work with patient organizations, researchers, the medical community and industry colleagues, these goals are indeed within sight."

A study On Fatigue in multiple sclerosis

2010-05-27T07:01:00.000-07:00

(Posted By: Josi Creek)

Study: Deep brain stimulation very good outcome for most patients with dystonia and tremor

2010-05-27T06:56:00.000-07:00

(Posted By: Josi Creek)

Low Prenatal Sunlight Exposure May Increase Multiple Sclerosis Risk

2010-05-24T13:27:00.000-07:00

(Posted By: Josi Creek)

Low maternal exposure to sunlight during the first trimester of pregnancy may increase the risk of offspring later developing multiple sclerosis (MS), a new Australian study suggests.

The study also uncovered an association between being born in the southernmost region of Tasmania and a subsequent elevated risk for MS.

The results of the study, which mirror research results of subjects living in the northern hemisphere, suggests that women considering getting pregnant should first determine their vitamin D levels, said study author Anne-Louise Ponsonby, PhD, professor, Murdoch Children's Research Institute, Royal Children's Hospital, Melbourne, Australia. "People should not go into a pregnancy low in vitamin D," she told Medscape Neurology.

The study also appears to indicate that there is more than 1 time point across the life course that might be important for MS risk, said Dr. Ponsonby.

Biogen Idec and Abbott Announce Enrollment of First Patient in Study of Daclizumab for Relapsing-Remitting Multiple Sclerosis

2010-05-24T08:20:00.000-07:00

(Posted By: Josi Creek)

Biogen Idec and Abbott today announced enrollment of the first patient in a global Phase III study evaluating the efficacy and safety of daclizumab compared to interferon beta-1a (AVONEX(R)) in patients with relapsing-remitting multiple sclerosis (RRMS), the most common form of multiple sclerosis (MS). The trial, called DECIDE, will investigate a subcutaneous formulation of daclizumab intended for monthly administration, which has the potential to provide a new immunomodulatory approach for treating MS. Under the terms of the collaboration agreement, Biogen Idec will make a $30 million milestone payment to Abbott. This payment is due upon enrollment of the first patient in the DECIDE trial.

"Despite significant advances in MS therapy, many patients continue to experience disease activity. The MS community is eager for new treatment approaches," said Ludwig Kappos, M.D., Head, MS-Research Group, University Hospital, Basel, Switzerland, and lead investigator for the study. "As shown in previous studies, daclizumab appears to selectively target immune cells that are thought to become activated in MS and cause damage to the central nervous system."

DECIDE is a global Phase III, randomized, double-blind, active-comparator study expected to enroll approximately 1,500 RRMS patients in 28 countries. The trial will investigate a subcutaneous formulation of daclizumab intended for once-monthly administration as a monotherapy compared to treatment with interferon beta 1-a, one of the most common treatments for MS. Daclizumab is also being investigated in the ongoing Phase IIb registration-enabling SELECT trial, which is evaluating the efficacy and safety of monthly subcutaneous doses of either 150 mg or 300 mg of daclizumab monotherapy.

Cannabis-based Sativex Multiple Sclerosis treatment set for UK approval

2010-05-21T07:51:00.001-07:00

(Posted By: Josi Creek)

Sativex, a ground-breaking cannabis-based drug for treating symptoms of multiple sclerosis (MS), could be approved in the UK by the end of June, its creator said on Thursday.

GW Pharmaceuticals has been developing Sativex, which eases muscle stiffness associated with MS, for more than a decade and on Thursday the drug maker said the medicine could be approved and launched in Britain by the end of next month.

A regulatory green light in Spain is expected shortly after, according to the company, which added that all major and minor issues relating to the application for Sativex's approval had been resolved.

The approval is now in its final stage, which involves finalising the wording on the product's packaging.

Sativex, which is sprayed under the tongue, is to be marketed in Britain by Germany's Bayer and in the rest of Europe by Spain's Almirall.

GW said both partners were well advanced in preparations for the Sativex launch and GW has manufactured stocks of Sativex for distribution immediately upon UK approval.

Sativex became the world's first cannabis medicine to win regulatory approval when it was given the go-ahead in Canada in 2005.

But, its roll-out in Britain, Spain and other European markets thereafter represents a much larger commercial opportunity.

Sativex is also being developed to treat pain in people with advanced cancer in partnership with Japanese company, Otsuka.

Dr Geoffrey Guy, the chairman of GW, said on Thursday: "The first six months of this year have proven the most important in GW's history in which we have made material progress towards Sativex's launch in Europe and generated positive cancer pain data."

GW Pharma reported a loss of £2.7m for the six months to end of March, compared to a £4m profit in the first half of 2009 when it had received an £8m milestone payment.

Analysts at Piper Jaffray said that UK regulatory approval would trigger first commercial sales and a £10m milestone payment from marketing partner, Bayer.

The broker anticipates that sales of Sativex in MS spasticity could reach £107m in Europe alone.

Roche And Biogen Idec To Discontinue Ocrelizumab Clinical Development for Patients With Rheumatoid Arthritis

2010-05-21T07:46:00.000-07:00

(Posted By: Josi Creek)

Roche and Biogen Idec announced the suspension of treatment in the ocrelizumab RA program. This decision followed a recommendation from the independent ocrelizumab RA & Lupus Data and Safety Monitoring Board (DSMB). The DSMB concluded that the safety risk outweighed the benefits observed in these specific patient populations at that time based on an infection related safety signal which included serious infections, some of which were fatal, and opportunistic infections. Subsequently, the U.S. Food and Drug Administration (FDA) placed the RA studies on clinical hold.

15-year follow-up study on Intramuscular Interferon

2010-05-20T09:51:00.000-07:00

(Posted By: Josi Creek)

A Study: Autoimmune Diseases prior to Multiple Sclerosis Diagnosis

2010-05-19T16:15:00.001-07:00

(Posted By: Josi Creek)

Alzheimer's Drug Trial On Multiple Sclerosis Patients for Cognitive Impairment

2010-05-19T08:00:00.000-07:00

(Posted By: Josi Creek)

A Study On The Probability of Divorce in Multiple Sclerosis Patients

2010-05-19T07:55:00.001-07:00

(Posted By: Josi Creek)

Acorda Therapeutics (Amprya) Recognized by National Organization for Rare Disorders for Contribution to Treatment of Multiple Sclerosis

2010-05-18T06:28:00.000-07:00

Acorda Therapeutics, Inc. today announced the National Organization for Rare Disorders (NORD) is recognizing the Company for its efforts to develop therapies for rare diseases. Earlier this year, Acorda received approval from the U.S. Food and Drug Administration (FDA) for AMPYRA (dalfampridine) Extended Release Tablets, 10 mg, the first therapy to improve walking in people with multiple sclerosis (MS). This was demonstrated by an improvement in walking speed. The award will be presented tonight at the 2010 NORD Partners in Progress Gala in Washington, D.C.

"NORD plays a critical role in advocating for public policies that encourage public and private investment in development of therapies for rare diseases. This effort helps to ensure that patients with rare diseases have hope for future treatments," said Ron Cohen, M.D., President and CEO of Acorda Therapeutics. "NORD is also an invaluable resource for people affected by rare diseases, providing information, education and support services to patients, families, medical professionals, and the public. We are honored to be recognized by an organization that has made such important contributions to medicine and society."

"Multiple sclerosis is a progressive disease with devastating health consequences, and new treatment options are needed to improve the lives of people with MS," said Peter L. Saltonstall, President and CEO of NORD. "We commend Acorda for its commitment to bringing novel therapies to market for people with MS and other neurological diseases."

New Clinical Trial Of Investigational Multiple Sclerosis Treatment

2010-05-18T06:17:00.001-07:00

(Posted By: Josi Creek)

Apitope, the European biotech company developing therapeutic peptides to treat autoimmune and allergic diseases, today announced the start of its second Phase I clinical trial of ATX-MS-1467, in patients with Multiple Sclerosis (MS).

MS is a chronic, inflammatory condition of the nervous system and is the most common, non-traumatic, disabling neurological disease in young adults, with most patients developing the disease between the ages of 20 and 40. The World Health Organization estimates that up to 2.5 million people suffer from MS worldwide with women affected 1.8 times more frequently than men.
ATX-MS-1467, an investigational peptide-based therapeutic derived from Apitope’s proprietary technology platform, has already completed successfully a Phase I clinical trial in six patients with secondary progressive MS (SPMS). This new Phase I study aims to build on the results from the initial study and investigates safety and proof-of-principle of ATX-MS-1467 in 40 patients with relapsing forms of MS (RMS).
The clinical trial will be carried out at up to ten sites across the UK.
Dr. Jeremy Chataway, Chief Investigator for trials, of the National Hospital for Neurology and Neurosurgery in London commented:
“I am excited to work with Apitope on the clinical trials of ATX-MS-1467. This has the potential to serve as a treatment option for patients with multiple sclerosis.”
The primary end point of the trial is safety and tolerability but secondary end points are designed to provide proof of principle. ATX-MS-1467 will be administered either intra-dermally or sub-cutaneously once every two weeks for 16 weeks, with a further 24 weeks of follow up.
Apitope is developing ATX-MS-1467 with Merck Serono, one of the leading pharmaceutical companies in the treatment of MS. Under the terms of the agreement between the two companies, Apitope is responsible for all Phase I development of ATX-MS-1467. Merck Serono will take over development of the compound at the beginning of Phase II clinical trials.

Researchers seeking 1,000 who have Multiple Sclerosis

2010-05-16T14:43:00.000-07:00

(Posted By: Josi Creek)

Duke University's medical research study at the N.C. Research Campus will recruit 1,000 people with multiple sclerosis to better understand how the unpredictable neurological disease progresses.

Ultimately, researchers want to find a cure for MS, which afflicts 400,000 Americans.

Regardless of where they live, all adults with MS can enroll in the MURDOCK Study, including people living in Salisbury and the rest of Rowan County.

Until now, only people living in Kannapolis and Cabarrus County could enroll in the study named for Research Campus founder and Dole Food Co. chairman David Murdock.

MS patients will give blood and urine samples, just like everyone who joins the MURDOCK Study registry, which aims to enroll 50,000 healthy and sick people overall.

MURDOCK stands for Measurement to Understand the Reclassification of Disease Of Cabarrus/Kannapolis.

North and South Carolina researchers will conduct genetic studies using the MS samples to better understand the disease at the molecular level. Currently, MS has no cure and is diagnosed by ruling out other ailments.

The MS samples will form a cohort, or special area of concentration within the MURDOCK Study.

Patients will not receive any intervention.

"This is not a drug study," said Dr. Russ Bodner, who treats about 100 patients with MS at NorthEast Neurology in Concord. "We are not testing to see if something works or doesn't work."

Researchers and physicians like Bodner who are collaborating on the cohort will follow the MS enrollees over time to see how their disease progresses.

"We will treat them as we would otherwise treat them and essentially look at how things move along," he said.

By working with clinicians like Bodner, research scientists will have a more complete picture of the disease, including environmental factors, said Dr. Simon Gregory, a Duke University scientist who serves as lead investigator for the cohort and has a lab at the Research Campus in Kannapolis.

Gregory, Bodner and others have submitted a $650,000 proposal to the National MS Society that, if funded, would form the first official MS consortium in North Carolina.

Called the Carolinas Longitudinal MS Study, the proposed consortium would bring together investigators with significant experience in treating or researching the disease.

The funding would pay to investigate whether signatures of MS progression can be found in body fluids of people with the disease, which rapidly debilitates some patients and has little effect in others.

"They are trying to unlock the progression question," said Dr. Ashley Dunham, community project leader for the MURDOCK Study.

Researchers will use MS samples for both parts of the genetic study, comparing rapid progressors to those whose disease has progressed slowly or even not at all.

"This helps them lean closer to a cure and the ability to diagnose people and tell them what their disease is going to be like on the front-end," Dunham said. "Just having that knowledge upfront would be huge."

Researchers want to understand the mechanism that causes the disease, Gregory said.

"Then we can start figuring out how to rectify the genomic situation," he said.

Gregory has been developing methods to identify genes responsible for complex disorders like MS and turning off the culprit genes.

Gene therapy, or inserting genes into cells, "promised a lot but delivered very little," Simon said.

Instead, researchers are focused on manipulating pathways, or how genes interact, to change the course of MS.

"Can we step in at a certain point and provide a more of a particular protein?" he said.

Most MURDOCK Study enrollment sites are located in Kannapolis and Cabarrus County. But Duke will open three new sites to target people with MS, including NorthEast Neurology in Concord, the Multiple Sclerosis Center in Charlotte and Neuroscience Associates in Greenville, S.C.

MS patients who are already in clinical trials can still enroll in the study's registry, Dunham said.

Duke is one of eight N.C. universities with a presence at the Research Campus, a life sciences complex in downtown Kannapolis where scientists study health, nutrition and agriculture.

"This is a unique opportunity. We've got a strong MS society, we've got Simon (Gregory), we've got the Core Lab, we've got local engaged collaborators," Dunham said. "This is an exciting project for us."

Other than adults with MS, only people who are 100 years or older may enroll in the MURDOCK Study if they live outside of Kannapolis or Cabarrus County.

To enroll, adults with MS should call the study at 877-673-2508 or go to www.murdock-study.com.

The National MS Society announced a partnership last year with the Research Campus to find a cure for multiple sclerosis.

Charlotte businessman and theater mogul Herman Stone pledged $1 million to a campaign called "On the Shoulders of Giants" that aims to raise $5.2 million for MS research, including funds to support Gregory's work at the Research Campus.

A Study: Copaxone (glatiramer acetate) Does not show significant affect on on Multiple Sclerosis Progression: Not affective for progressive forms

2010-05-14T18:14:00.000-07:00

(Posted By: Josi Creek)

FDA denies Teva bid to block generic Copaxone

2010-05-14T06:56:00.000-07:00

(Posted By: Josi Creek)

The US Food and Drug Administration has once again rejected Teva Pharmaceutical Industries’ request to stop approval of any generic versions of the Israeli company’s multiple sclerosis blockbuster Copaxone.

Last year, Teva asked the FDA to block copycat versions of Copaxone (glatiramer acetate) after the agency had accepted for review Abbreviated New Drug Applications from Momenta Pharmaceuticals and Novartis unit Sandoz, as well as Mylan. The Petah Tikva-headquartered firm’s argument was that Copaxone is “a complex mixture of the acetate salts of synthetic polypeptides” and due to “the variability of the composition of the polymers”, it believes that “replicating this formulation would be extremely difficult”.

However the FDA rejected that claim and has now turned down a second Citizen’s Petition for the same reason, namely that it would be “premature and inappropriate” to grant Teva's requests. The agency speaks of its “broad discretion" in determining whether the submitted information by Momenta/Sandoz and Mylan, or anyone else, is enough to conclude that a generic is the same as the original.

The FDA adds that “a finding of sameness does not, however, necessitate a finding of ‘complete chemical identity’. Thus, the agency may consider other criteria to determine sameness, taking into account the complexity of the active ingredient”.

Despite this latest rejection, the FDA said the information in Teva's letter will help it assess of the types of information required to support generic Copaxone. The world’s biggest generics firm has already sued Momenta/Sandoz and Mylan which means that no generic version can enter the US market until early 2011.

First-quarter sales of Copaxone reached $796 million, an increase of 28%.

A study: Case of Long survival and clinical stability in Deadly variant of multiple sclerosis

2010-05-13T14:28:00.002-07:00

(Posted By: Josi Creek)

"Marburg's variant multiple sclerosis is an acute and aggressive atypical form of MS, leading frequently to death in few months. "

FDA To Target Misleading Drug Ads

2010-05-12T15:20:00.002-07:00

(Posted By: Josi Creek)

"Last month, FDA sent a warning letter to Biogen Idec, Inc., for downplaying the risks of progressive multifocal leukoencephalopathy (PML), a rare, but often fatal, brain infection that has been linked to the multiple sclerosis drug Tysabri. The statements were made in a series of webcasts used to promote the drug between late October and early November of 2009."
Federal drug regulators are hoping to recruit doctors in the hunt for misleading drug advertisements through a new initiative aimed at marketing materials that provide inaccurate or misleading information, or make statements that downplay or omit the negative side effects of drugs.

The FDA unveiled its new “Bad Ad Program” this week, which is sponsored by the agency’s Division of Drug Marketing, Advertising, and Communications (DDMAC). The program is aimed at getting health care providers to pay more attention to presentations and advertisements, and FDA officials hope it will give them an eye into private promotional activities where FDA regulators are not present.

The agency will focus on providing educational materials to doctors, bringing attention to the most common forms of misleading drug advertisements. Health care professionals will be encouraged to report potential violations at badad@fda.gov. They will be allowed to report anonymously if necessary.

“The Bad Ad Program will help health care providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency,” according to Thomas Abrams, director of DDMAC.

The new program comes after a number of drug makers were warned by FDA about misleading advertisements; many of which were at conferences or in internet videos targeting health care providers.

Last month, FDA sent a warning letter to Biogen Idec, Inc., for downplaying the risks of progressive multifocal leukoencephalopathy (PML), a rare, but often fatal, brain infection that has been linked to the multiple sclerosis drug Tysabri. The statements were made in a series of webcasts used to promote the drug between late October and early November of 2009.

In January ,the FDA fired off warnings to Amylin Pharmaceuticals, Eli Lilly and Co., Bayer Healthcare Pharmaceuticals and Cephalon. In the letter to Amylin, the FDA cited the company for promoting Byetta as a stand-alone diabetes drug at the Endocrine Society’s Annual Meeting, before it was approved as such. Eli Lilly was warned that its direct-to-consumer print advertisements for the antipsychotic Cymbalta buried health risk information and made it appear unrelated to the drug. Cephalon was cited for omitting health risk information on pocket dosing cards for Treanda, a leukemia medication.

Bayer Healthcare also received a letter accusing the company of overstating the effectiveness of the Mirena intrauterine device (IUD) and minimizing health risks in a live consumer-directed program where representatives travel to consumers’ homes.

Bayer has run into trouble in the past with the FDA over marketing claims involving its contraceptive products. In late 2008, the FDA and several state attorney generals forced Bayer to run a $20 million corrective advertising campaign for its Yaz birth control pills because prior marketing contained false claims about the drug’s acne and PMS-fighting benefits, and did not clearly state all of the known Yaz side effects, drowning some of them out with loud music. As a result of the misleading advertisements, Bayer agreed that the FDA will screen future Yaz ads for six years before they can be aired.

Repeat Rituxan ( Rituximab) Therapy Helps in Resistant Rhumatoid Arthritis

2010-05-12T07:17:00.001-07:00

(Posted By: Josi Creek)

Most patients with resistant rheumatoid arthritis who failed to respond to an initial cycle of rituximab (Rituxan) showed clinical improvement following a second treatment cycle, a British study found.

I wonder how this will effect those with MS who are taking Rituxan. Perhaps the results of this study show promise for both Multiple Sclerosis and Rhumatoid Arthritis patients.

Six months after cycle 2, significant improvements were seen on disease activity scores compared with scores either at baseline or immediately before retreatment(P<0.001 for both), according to Edward M. Vital, MBChB, of the University of Leeds, and colleagues.

In addition, almost three-quarters of patients had moderate or good responses, according to the criteria of the European League Against Rheumatism (EULAR), the researchers reported in the May issue of Arthritis & Rheumatism.

Rituximab is a chimeric monoclonal antibody against the CD20 protein, which is found primarily on the surface of B cells.

In rheumatoid arthritis, this B-cell depleting agent is generally reserved for patients who do not respond to conventional disease-modifying medications such as methotrexate or to antitumor necrosis factor (TNF) drugs.

"Consequently, patients who do not exhibit an adequate response to rituximab have frequently exhausted all other available therapy options, and treatment of these patients is challenging," Vital and colleagues explained.

Initial studies of rituximab suggested that the drug completely depleted B cells, and that a lack of response might reflect B-cell–independent mechanisms in some patients.

However, the development of more sensitive methods of measuring circulating B cells has demonstrated otherwise.

Highly sensitive flow cytometry has shown that almost all patients who do not show a clinical response have incomplete B-cell depletion, especially in the synovium.

To see if an additional cycle of treatment could enhance depletion and lead to clinical response, the investigators treated 25 nonresponders with two infusions (each 1 gram) of rituximab, at least six months after the first pair of infusions but before B-cell repopulation had occurred.

To be classified as a EULAR responder (either moderate or good), patients must have a significant change in their disease activity scores and low current disease activity.

Total B-cell levels and levels of all circulating B-cell subtypes (naive, memory, and preplasma cells) were higher at baseline in first-cycle nonresponders. Most cells that remained three months after the first cycle were preplasma cells.

Six months after the second rituximab cycle, 38% of patients had complete B-cell depletion. In contrast, among the nonresponders only 9% had shown complete depletion after the first cycle.

After retreatment, 72% were classified as responders, 32% had a good response, and 16% were in remission.

In both cycles, good or moderate EULAR responses were seen in 50% of patients with complete B-cell depletion, but in only 31% of those without complete depletion.

Nine of the patients who responded to the second cycle experienced a relapse at a median time of 11 months post-treatment.

"These findings have a number of implications for understanding the role of B cells in RA, for using treatment to target them effectively, and for developing a rational approach to the management of resistant RA," the investigators wrote.

For instance, unlike naive and memory B cells, preplasma cells do not express CD20 and therefore are not directly targeted by rituximab.

The persistence of preplasma cells in circulation suggests continuing B cell activity at sites such as the synovium, and nonresponders also may have more B-cell tissue infiltration, they explained.

The finding that B-cell depletion could be increased with additional cycles of rituximab was "not necessarily expected," they commented.

"A number of factors have been suggested as potential contributors to inadequate depletion after treatment with rituximab, and not all of them could necessarily be overcome by a higher dose."

For example, polymorphisms of the Fcγ receptor have been shown to influence the degree of depletion during treatment with rituximab for lymphoma and systemic lupus erythematosus. Effects of these polymorphisms have not yet been explored in rheumatoid arthritis.

In addition, some patients develop human antichimeric antibodies following exposure to rituximab, which could result in less depletion in subsequent treatment cycles.

Baseline B-cell levels and early depletion now can be used as biomarkers for response to rituximab, but these findings must be confirmed in larger studies, the investigators cautioned.

Other strategies that could be tried for nonresponders include the use of a different B-cell depleting agent or a different dose during the initial cycle.

"Our findings indicate that the full potential of B-cell-depleting therapies has not been realized by current approaches and that more patients than previously thought may benefit from this therapy if its use is refined," they observed.

Study to Examine Emotional side of Multiple Sclerosis Looking For Participants

2010-05-11T23:25:00.000-07:00

(Posted By: Josi Creek)

How do people with multiple sclerosis emotionally adjust to living with the debilitating disease?

That's the focus of a study by Melissa Kehler, a University of Regina doctoral psychology student, who is looking for 400 adult Canadians with MS to complete a one-time questionnaire that is available either online or in paper format.

The anonymous and confidential questionnaire takes about an hour to complete and includes questions about anxiety and depression as well as quality of life, coping and MS-related disability.

Research has found that up to 50 per cent of people with MS experience depression at some point in their lives.

"Because MS is so variable, you've got people who might have much more limited physical effects of MS, and you've got people on the other end of the spectrum who are very strongly affected physically by MS," Kehler said. "And so we might think, 'You have this condition and you don't know what's going to happen to you in the future, why wouldn't you be depressed?' "

She wonders what factors protect people from experiencing symptoms of anxiety and depression and what helps people experience a more positive quality of life.

Kehler said her research will look at "a variety of different factors" to try and answer such questions.

For every participant who completes the questionnaire, $1 will be donated to the Multiple Sclerosis Society of Canada, and participants are eligible for a monthly draw.

Kehler said the study might lead to valuable information for clinicians about what information they should gather about a patient's level of adjustment and will also provide information that could be used to develop interventions.

To participate or find out more information, go to http://uregina.ca/ 7/8hadjista/MS—Study.html

Liberation Procedure (CCSVI) for Multiple Sclerosis lands Victoria BC surgeon in hot water

2010-05-11T23:00:00.001-07:00

(Posted By: Josi Creek)

The B.C. woman who had the experimental neck vein procedure defends the treatment

A B.C. woman is crediting an experimental procedure with clearing up her multiple sclerosis symptoms, even if the treatment earned her Victoria doctor a professional rebuke.

Kornelija Valentic, a 38-year-old mother of three from the Vancouver suburb of Surrey, said she was nearly disabled by MS.

All she hoped to get from last's month procedure to open the veins in her neck was an end to her constant headache.

But within 48 hours of the operation, she was walking better, her vision improved, she recovered feeling her hands and feet and regained control of her bladder.

"I wanted the headaches gone," said Valentic in a telephone interview. "My little bonus is being able to make it to the bathroom, being able to see, hand-tremors that are gone and I can drink my coffee without spilling anything.

"I wasn't expecting it. But you know what? I'll take it," she said.

But last week, she learned that the Victoria radiologist who performed the procedure, along with one other, had been chastised by medical officials at the Vancouver Island Health Authority for performing the experimental procedure outside of an approved trial.

The treatment, known as "liberation procedure," was first reported in 2008 by an Italian vascular surgeon named Dr. Paolo Zamboni.

Zamboni theorized many of the symptoms associated with the disease — pain, crippling fatigue, blindness and progressive paralysis — are the result of an iron build up in the brain.

In the "liberation procedure," a small balloon is inflated in the veins that carry blood away from the brain, similar to an angioplasty.

Zamboni's theory radically challenged medical scientific opinion about MS.

Previously it was considered a disease where the body's immune system attacked the fatty, insulating coating on the nerves — called myelin — destroying the nerve's ability to transmit signals to and from the brain.

Clinical trials are now being fast-tracked across the world, including at the University of B.C. and McMaster University in Hamilton.

But MS patients do not want to wait.

They have been paying thousands of dollars to fly to Italy, Poland and, most recently, India to get the treatment.

Last week, MS patients and their families demonstrated across Canada, asking governments to start funding the procedure.

But doctors and medical officials are unwilling to push through an experimental procedure without the recognized trial studies.

Eike Kluge, a philosophy professor at the University of Victoria, who specializes in bio-medical ethics and has testified in court in the field, said doctors are right to demand the trial studies.

Doctors are ethically bound to only intervene or prescribe treatment based on properly derived scientific evidence, he said.

Kluge agreed it's tragic for a patient to be denied a possible treatment because not enough time has passed for the completion of clinical trials — but that doesn't make the government's decision wrong.

"Something may very well be tragic, but that doesn't make it unethical," he said. "Life is tragic. We are all going to die. That doesn't make it unethical."

A Study: Health Toll On the Multiple Sclerosis Caregivers; What can be Done

2010-05-11T19:30:00.004-07:00

(Posted By: Josi Creek)

Zebrafish may hold the Key to Restoring Myelin

2010-05-11T19:19:00.002-07:00

(Posted By: Josi Creek)

A Medical Publication: Genes may play a role in Multiple Sclerosis patients response to Interfrerons

2010-05-11T19:16:00.000-07:00

(Posted By: Josi Creek)

A study: additional eye damage in multiple sclerosis patients with or without optic neuritis

2010-05-11T19:05:00.000-07:00

(Posted By: Josi Creek)

BERLENA HAS PHOTOS & AN AMAZING STORY ABOUT HOW AMPYRA HELPED HER WALKING ON HER CRUISE!

2010-05-11T18:14:00.001-07:00

(Posted By: Josi Creek)

CLICK HERE TO GO TO OUR FACEBOOK PAGE & READ COMMENTS & (((HUGS)) OUR Facebook FRIENDS LEFT FOR

BERLENA

AND CLICK HERE TO READ 1000'S OF OTHER STORIES ABOUT OUR 2,700 Facebook FRIENDS LIKE BERLINA'S BELOW:

Stan, This is a comment my son made after looking at one of our pictures taken on the cruise ......... "Where did you take this?!?"! LOL! Very nice! I always enjoy hangin out with you and Pops...Broham (Pops) is finally coming around!...As for you, I'm so glad that you continue to take things in stride and don't let things stop you!....Just like a true Spencer!...Luv ya both!

Stan, as promised an update on my vacation. We took a 7 day Southern Caribbean cruise from San Juan, Puerto Rico. We went on 3 tours and I've never been on a cruise where transportation wasn't provided to get to the main shopping area after leaving the ship. Only one place had transportation and that was St. Maarten. The other ports we had to walk to the area. I usually walk along with my husband, but there were times I ventured to some stores alone.

This I've never done before. The steps on the ship to get to the upper deck I usually don't do, but every port we went into and when we got ready to sail away, I climbed the steps and went to the top deck.

I guess I'm rambling on, but the point I'm getting to is that I know Ampyra is working because I never would have been able to walk as much as I did on our cruise if I weren't taking it.

My son took a picture of me going up the steps, and my daughter-in-law commented on how I was coming up the steps. I took a 1/2 provigil for 3 days to be able to stay awake longer, but that was it. It was hot, but I was able to deal with it, just made sure I stayed hydrated.

I still use my cane, and I'm not able to run a marathon, probably couldn't anyway at my age, but I'm so thankful for the change I've noticed since starting ampyra.

When we got back, my son called to check on us, and he said once again that he and his wife had talked about how my mobility has improved.

This Saturday will be 8 weeks since starting ampyra. So far there has been no side effects, and there's definitely speed in my walking.

Pictures will follow Stan!!

Tysabri (natalizumab) may interfere with central nervous system immune surveillance.

2010-05-11T10:53:00.001-07:00

A study about the immune system of the central nervous system itself, and how it is negatively affected by Tysabri. Could this could lead to further explinations for the cause of the many cases of PML?