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.