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Saturday

 

Diagnosing and managing multiple sclerosis.

The most common form of MS is relapsing remitting MS (RRMS). This is now a treatable condition and early diagnosis is becoming increasingly important in order to guide management decisions. After several years, RRMS may evolve into a slowly progressive deterioration in neurological function, known as secondary progressive MS. In 10-15% of people with MS, the condition follows this pattern of slow deterioration from onset, without relapses or remissions. This is primary progressive MS. It is difficult to predict prognosis in an individual patient. Factors associated with a favourable prognosis include female sex, onset with optic neuritis or sensory symptoms (rather than weakness or ataxia) and a long interval between initial relapses. RRMS is most commonly diagnosed in white women in their 20s. The first attack is known as a 'clinically isolated syndrome' reflecting inflammation in a single location. Common sites and symptoms are: optic nerve; spinal cord; sensory symptoms; Lhermitte's symptom and brainstem. The time course of symptoms is often helpful, as it is characteristic of inflammation. Patients tend to deteriorate over days, remain at a nadir for a week or two, and then recover over weeks. Recovery may be incomplete. Question patients directly to find out if there is a past history of any of the other common symptoms and perform a full neurological examination. Primary progressive MS should be suspected in patients presenting with a progressive spastic paraparesis or cerebellar syndrome. The diagnosis of MS should be made by a specialist and patients with a syndrome suggestive of MS should be referred to a neurologist. The mainstays of pharmacological treatment in RRMS are still the beta interferons and glatiramer acetate. These drugs reduce the rate of relapse by about a third and are therefore indicated for mobile patients with at least two relapses in the past two years. - Practitioner. 2009 Sep;253(1721):25-30, 2-3. in PubMed

 

More Tysabri Problems; Time for a Biogen-Idec Credibility Check


Unsubstantiated whisperings about Biogen Idec and its controversial multiple sclerosis drug took an ugly turn to the truth on Thursday when Europeon regulators disclosed another new case of progressive multifocal leukoencephalopathy, a serious brain infection known as PML, in a relapsed MS patient receiving Tysabri (natalizumab) infusions. With 11 new cases in two months, Biogen is going to face some awkward questions that will challenge the credibility of the company — and its promising MS franchise:

What did they know?

How long have they known it (more PML cases)?

And, how safe are other drugs in the MS pipeline?

In response to an email I wrote to the FDA inquiring as to how many confirmed cases of PML were on file — and were more reports to be expected — spokeswoman Sandra Walsh would only say:

"Yes, there are 24 confirmed cases of PML (since Tysabri re-marketing in 2006). The FDA is still receiving and reviewing follow-up information on cases of PML so we cannot yet comment further.

We’ll keep you posted as we learn more."

The global press will likely scapegoat Biogen management, accusing officials of withholding clinical data on side effects culled from Tysabri-treated patients. Before criticizing chief executive Jim Mullen & Co., however, the American public needs to remember that all current and emerging biological therapies for immune-mediated diseases, such as rheumatoid arthritis, Crohn’s disease, and MS, are imperfectly understood at best. The actual mechanism by which most of these drugs work is often murky, and they can cause unknown side effects as well:
Increasing numbers of invasiv e fungal infections are being reported in patients who have autoimmune inflammatory diseases and are being treated with newer immunosuppressive drugs, such as the well-known tumor necrosis factor (TNF)-alpha antagonist Enbrel (Etanercept), the anti-CD52 antibody Campath (alemtuzumab), or the interleukin-2 receptor antibody Simulect (basiliximab). [Current Infectious Disease Reports, 2009 Nov; 11(6): 435-8]
Or, as Ralf Gold, a well-respected neurologist in residence at Ruhr-University, located in Bochum, Germany, pointed out in a paper published in the New England Journal of Medicine:

“new MS drugs unfortunately have new side effects that can sometimes be fatal. Currently Natalizumab is the focal point of interest throughout the world, but [that] other new drugs, such as Alemtuzumab or anti-CD20 antibodies may soon follow.”

Still, all stakeholders, especially MS patients, have the right to feel both betrayed and angry, as Biogen management appeared to be both evasive and equivocal when answering queries from biotech analysts on the October 20 third-quarter earnings call. For example, as up to 17 worldwide cases of PML had been reported prior to third-quarter end, Eun Yang, biotech analyst at Jeffries & Co, asked management about emerging data suggesting there was a link between duration of Tysabri therapy and increased risk of developing PML.

“When you look at the patients who have been on the treatment for 24-months or longer, PML rate runs around 1 in 800, which is higher than what is in the [prescribing] label,” said Yang. “So, my question to you is what do you think would be the critical threshold of a PML rate where physicians or regulatory agencies would become more cautious on Tysabri?”

“I don’t want to speculate what makes regulators want to do things,” responded chief operating officer Bob Hamm, “but I can assure you that our current thinking is that the risk of PML even in that third year beyond 24-months is within the currently implied risk in the label.”

The current rate of PML in patients who had received at least 24 infusions ranges from 0.4 to 1.3 per 1,000 - patients, according to an FDA Safety Alert Update posted on September 16.
Management also downplayed any safety advantage to “drug holidays” for long-term Tysabri users. Specifically, when asked to comment on the proportion of patients in Biogen’s database where providers implemented drug holidays, senior researcher Al Sandrock tersely replied: “From the data we have — we are seeing very, very isolated cases of that.”

As I referenced in an earlier BNET Pharma posting, about 13,400 patients receiving monthly infusions (or approximately 29 percent of all patients taking the drug) had been on Tysabri therapy for more than two years — paying, on average, $28,500 per year for 13 infusions. It’s easy to do the math, subtract number of infusions and units sold decline.
Short-term, in my opinion, physician and patient distrust could lead to Tysabri (once again) losing market share to Teva Pharmaceutical’s (non-interferon) immunomodulator Copaxone (glatiramer acetate), with harmless injection-site reactions the most annoying of reported adverse events. Data from a 15-year ongoing Copaxone prospective study demonstrating patients treated for 10 and 15 years with the drug had significant reduction in disease severity should stimulate growth in sales, too.

“To stumble twice against the same stone is a proverbial disgrace, ” said the great Roman statesman Marcus Cicero. Not that Jim Mullens need give a Richard Nixon-like Checkers speech: “My fellow Americans.” The goal of Biogen management, nonetheless, is the same as Nixon’s was 50 years ago — damage control with humility. Admit (without admitting liability) that PML is more prevalent than original surveillance data suggested and move forward, working with MS interest groups and the FDA and European regulators to strengthen distribution and monitoring programs at Tysabri infusion centers worldwide. Also, Mullens should remind providers that the drug’s demonstrated 67 percent reduction in the relapse rate tips the risk-benefit scale in Tysabri’s continued favor.

The importance to Biogen of retaining credibility cannot be understated, as the company is racing against European drugmakers Merck KGaA (cladribine) and Novartis AG (fingolimod) to introduce the first oral pill for MS to market. Biogen agreed back in July to pay up to $510 million to market Fampridine SR (sustained-release), an oral tablet owned by Acorda Therapeutics, outside the United States.

The FDA’s Peripheral and Central Nervous System Drugs (PCNSD) Advisory Committee voted 12 to 1 that clinical data on Fampridine-SR 10 mg twice daily, which will sold under the brand name Amaya, has demonstrated substantial evidence of effectiveness as a treatment to improve walking in MS patients. Most experts agree that the drug could likely be on pharmacy shelves in the U.S. by the second quarter of 2010.

Biogen Idec expects to file for approval by the European Medicines Agency (EMEA) in early 2010. However, an unknown here and abroad is whether the therapy will receive a boxed warning for seizure risk (side effect looks to be dose-related). Consequently, the key issue to early adoption by physicians of Fampridine SR will likely, once again, turn on credibility — do neurologists trust Biogen Idec?

Story in BNET

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Disease progression among multiple sclerosis patients before and during a disease-modifying drug program: a longitudinal population-based evaluation

Randomized controlled trials have demonstrated the efficacy of disease-modifying drugs (DMDs) in persons with relapsing–remitting multiple sclerosis (MS) and secondary progressive MS with superimposed relapses. ........Multiple Sclerosis 2009, doi:10.1177/1352458509350307 in Sage Journals Online

 

Senators push for pardon of Franklin man with MS charged with growing marijuana


SOMERSET COUNTY — As he gets ready to go to trial for growing marijuana in back of his rented Franklin, Somerset County, home, John Ray Wilson has garnered some influential support.


Wilson suffers from multiple sclerosis and was trying to alleviate the pain of the disease with home-grown marijuana. But growing marijuana in New Jersey can lead to harsh penalties and the law make no concessions for people like Wilson.

This week state Sen. Nicholas Scutari and state Sen. Raymond Lesniak, both D-Union, called the prosecution of Wilson a "severe, inappropriate, discompassionate and inhumane application of the letter of the law."

They are seeking a pardon from Gov. Jon S. Corzine for the man on the first-degree charge of maintaining or operating a drug manufacturing facility. It can bring a sentence of up to 20 years in prison.

A four-year plea deal is on the table. But Lesniak said even that could ensure that Wilson would die behind bars.

Prosecuting people like Wilson "wasn't the intent of the legislation," of the drug manufacturing statute, Lesniak said. "It was designed to go after drug kingpins. This is hardly the case."

Wilson is facing two other charges, a second-degree manufacturing charge and a third-degree possession offense. The second-degree charge can bring five to 10 years in prison; a third-degree offense, three to five years.

Lesniak said they have not sought an outright pardon since Wilson must face consequences if found guilty. Community service would be a more appropriate sentence, Lesniak said.
A tentative trial date has been set for Dec. 14.

"We're moving ahead with the case," said David Wald, spokesman for the state Attorney General's office.

Robert Corrales, spokesman for Corzine, declined to discuss the request for the pardon.
"It would be inappropriate for us to comment on an ongoing investigation," he said. ... full story in myCentralJersey.com

 

Europe Takes Closer Look At Tysabri

A European panel has started a review of the controversial multiple sclerosis drug Tysabri, sold by Biogen Idec Inc. and Elan PLC, citing a higher rate of a rare brain infection than previously disclosed.

The additional cases are important because they may increase the drug's risk profile and raise questions about the companies' responsibility in updating the market on the safety record of Tysabri, a product that generates nearly $1 billion in yearly revenue.

The European Medicines Agency's Committee for Medicinal Products for Human Use, known as CHMP, reported there have been 23 cases of progressive multifocal leukoencephalopathy, or PML, ... full story in TheWall Street Journal

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European panel reviewing infections linked to Tysabri

Shares of transatlantic biotechnology partners Biogen Idec Inc. and Elan Corp. tumbled yesterday after European regulators said they were examining 23 cases of patients who developed potentially fatal brain infections after taking the companies’ multiple sclerosis drug Tysabri. That is twice as many cases as previously reported.

The European Medicines Agency, which regulates drugs in Europe, said it will review the risks and benefits of Tysabri and discuss whether added measures are needed to assure safety.

Biogen Idec spokeswoman Jennifer Neiman said the incidents of the brain infection, progressive multifocal leukoencephalopathy, remain extremely rare - well within the range of one in 1,000 cases noted on the drug’s label.

“Tysabri is a very compelling option for the treatment of multiple sclerosis,’’ Neiman said, “and overall, the benefit-risk profile for the product continues to be very favorable.’’ She said Tysabri is the only MS therapy that has been shown to stop - and in some cases reverse - the progression of the disease.

Al Sandrock, senior vice president and head of neurology research and development at Biogen Idec, said the company was discussing with global regulators a change to the wording on Tysabri’s label that would reflect an increased risk the longer patients took the drug. ...full story in Boston.com

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Teva rivals advance on oral MS drug: Merck KGaA and Novartis have completed Phase III trials of their drugs, and are filing for approval.

Oct 01, 2009 (Globes - McClatchy-Tribune Information Services via COMTEX) -- TEVA Quote Chart News PowerRating -- The ring around Copaxone, Teva Pharmaceutical Industries Ltd.'s (Nasdaq: TEVA; TASE: TEVA Quote Chart News PowerRating) treatment for multiple sclerosis, is tightening. Yesterday, two of Teva's main rivals developing oral treatments for the disease announced that they were applying for approcval of their drugs by the US Food and Drug Administration (FDA). Teva is also trying to develop an oral version of Copaxone.

Germany's Merck KGaA (XETRA: MRK) filed for approval of its multiple sclerosis pill cladribine, two months after filing for EU approval, and Switzerland's Novartis AG (NYSE:NVS; LSE: NOV; SWX: NOVZ) is seeking approval for its drug, FTY720, in both the US and Europe.

Copaxone generates 30-35 percent of Teva's net profit. The drug is administered by injection, and is considered a safe drug. Teva is undergoing a Phase II clinical trial for oral Copaxone.
Novartis announced successful results of the Phase III clinical trial of FTY720.

The company said that the drug delayed development of multiple sclerosis by two years, but that there were dangerous side effects if the drug was taken in high dosages, including high blood pressure, and skin cancer.

Merck KGaA has completed its Phase III clinical trial, which showed in January that cladribine reduced the number of relapses per year in patients with some forms of multiple sclerosis by 58 percent, compared with a placebo. However, the drug is considered as risky as FTY720. Market sources believe that cladribine will come on the US market in the second quarter of 2010, and European market launch in the fourth quarter of 2010. ....full story in TradingMarkets.com

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Luteolin as a therapeutic option for multiple sclerosis

Multiple sclerosis (MS) remains without an effective treatment in spite of intense research efforts. Interferon-beta (IFN-beta) reduces duration and severity of symptoms in many relapsing-remitting MS patients, but its mechanism of action is still not well understood.

Moreover, IFN-beta and other available treatments must be given parenterally and have a variety of adverse effects. Certain naturally occurring flavonoids, such as luteolin, have anti-oxidant and anti-inflammatory effects, including inhibition of activated peripheral blood leukocytes from MS patients.

Luteolin also inhibits mast cells, as well as mast cell-dependent T cell activation, recently implicated in MS pathogenesis. Moreover, luteolin and structurally similar flavonoids can inhibit experimental allergic allergic encephalomyelitis (EAE), an animal model of MS in rodents.

An appropriate luteolin formulation that permits sufficient absorption and reduces its metabolism could be a useful adjuvant to IFN-beta for MS therapy. ...story in 7th Space

 

Avanir's Zenvia Reports Good Trial Results; Shares Jump

Avanir Pharmaceuticals Inc. (AVNR) disclosed late-stage trial data which showed its drug Zenvia met all secondary endpoints in treating the psuedobulbar effect in patients with underlying multiple sclerosis. ......full story available through the Wall Street Journal

 

Fluid-Attenuated Inversion Recovery Magnetic Resonance Imaging Detects Cortical and Juxtacortical Multiple Sclerosis Lesions

FLAIR can detect many cortical and juxtacortical lesions in MS, which were appreciated previously in autopsy studies but usually missed by magnetic resonance imaging during life. Cortical and juxtacortical plaque formation may contribute to cortical atrophy in MS. - Arch Neurol. 2001;58:742-748.

 

Two-year data confirm efficacy of novel MS drug


A new type of immunomodulator could be the first orally administered treatment for multiple sclerosis, if an approval application expected later this year is successful.

Fingolimod, which is being developed by Novartis, binds to sphingosine 1-phosphate receptors on lymphocytes. The drug effectively ‘traps' lymphocytes in lymph nodes, reducing the number of cells circulating in the bloodstream and thereby lessening nerve inflammation.

Recently released data from a two-year Phase III trial show that fingolimod significantly improved two key disease measures in 1272 patients with relapsing-remitting multiple sclerosis. In the FREEDOMS study, fingolimod reduced annualised relapse rates by up to 60% and cut the risk of disability progression by as much as 32% compared with placebo.

The two doses of fingolimod tested, 0.5mg and 1.25mg once daily, exhibited comparable efficacy. However, investigators observed fewer adverse events at the 0.5mg dose than the 1.25mg dose. The lower dose is likely to be the focus of the drug's approval application.

"FREEDOMS reinforces the potential for fingolimod as a significant breakthrough in the future treatment of relapsing-remitting MS," said study investigator David Bates, Professor of Clinical Neurology at the University of Newcastle upon Tyne. "These results mean that a patient who would have had an attack every three years might expect one only every six to seven years. This, in itself, reduces the degree of disability."

In an earlier one-year Phase III study (TRANSFORMS) in relapsing-remitting multiple sclerosis, fingolimod reduced relapse rates significantly more than interferon beta-1a.

A third pivotal study of fingolimod (INFORMS) is ongoing in patients with primary progressive multiple sclerosis.


Friday

 

More PML Troubles for Biogen, Elan MS Drug: Biobuzz

CAMBRIDGE, Mass. (TheStreet) -- European regulators confirmed that 24 multiple sclerosis patients treated with Tysabri have contracted a serious brain infection. Four of those patients have died, according to the investment bank UBS.

The new disclosure concerning the link between Tysabri treatment and progressive multifocal leukoencephalopathy, or PML, pushed shares of Biogen Idec (BIIB Quote) and Elan(ELN Quote), makers of Tysabri, lower in Thursday trading.

Last week, European regulators launched a new safety review of Tysabri after it was disclosed that 23 multiple sclerosis patients treated with Tysabri had contracted PML since the drug was relaunched in 2006. The number of PML cases tied to Tysabri was much higher than investors had previously known.

The 24 cases of Tysabri-linked PML and four patient deaths was disclosed Thursday in an email sent by European regulators to UBS drug analyst Martin Wales, who was seeking more information about the link between Tysabri and PML cases. The email has been circulated across Wall Street trading desks this morning. A copy of the email, obtained by TheStreet, states:

"We can confirm that to date, 24 confirmed cases of PML have been reported worldwide since Tysabri has been on the marked in the EU in 2006.[Fourteen] of these ocurred in the EU, 8 in the US and 2 in Switzerland. Four patients died. Most of the cases were reported in patients who have had 24 or more infusions of Tysabri.
Story in TheStreet.com

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Data points out paths to Tysabri rehab

The news that 23 Tysabri patients had developed the brain malady PML hit Biogen hard earlier this week. Some analysts now say that the estimated risk of developing PML--1 in 1,000--might actually be more like 1 in 400. But two new possibilities for fighting PML have emerged, raising hopes that the potentially fatal brain infection can a.) be better prevented, and b.) better treated.

As BNet Pharma reports, a disproportionate number of PML cases have occurred in Germany. Why might that be? Well, oversight isn't quite as rigorous there as it is in the U.S., where Tysabri use is governed by a strict risk management program. By contrast, European distribution goes largely unrestricted. Also, Germany reportedly has been lax about making sure patients get completely free of other immunosuppressants before going on Tysabri, among other things. Biogen has been working with German clinics and academic medical centers to change that.

Meanwhile, a researcher at Elan--which discovered the drug--tells Forbes he's working on a diagnostic test that could screen patients for their risk of developing PML (progressive multifocal leukoencephalopathy). Tysabri suppresses the immune system, which can allow a dormant pathogen--the JC virus--to go into overdrive, causing PML. Previously, researchers thought 90 percent or more of us were infected with that virus, but Elan's Ted Yednock says his team has discovered an infection rate of 50 percent.

A diagnostic test could identify those patients who aren't infected, and thus are free and clear for Tysabri treatment. And those who have the virus could be closely monitored for symptoms.

Read more: http://www.fiercepharma.com/story/data-points-out-paths-tysabri-rehab/2009-10-28#ixzz0VOCZAWP3

Story in FiercePharma

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Thursday

 

What's new for Multiple Sclerosis in PubMed

Does Functional Electrical Stimulation for Foot Drop Strengthen Corticospinal Connections? - The large increases in MVC and MEP suggest that regular use of a foot-drop stimulator strengthens activation of motor cortical areas and their residual descending connections, which may explain the therapeutic effect on walking speed. - Neurorehabil Neural Repair. 2009 Oct 27. [Epub ahead of print] in PubMed

Cochlear implantation in a profoundly deaf patient who also suffers from multiple sclerosis - a case study. - Cochlear Implants Int. 2009 Oct 26. [Epub ahead of print] in PubMed

A cross-sectional study of bone health in multiple sclerosis. - Patients with multiple sclerosis (MS) often have multiple risk factors for osteoporotic fractures. Many patients with MS with low bone mass or previous fractures are not taking supplemental calcium or vitamin D, suggesting a potential area of improvement in care. - Neurology. 2009 Oct 27;73(17):1394-8. in PubMed

Autologous haematopoietic stem cell transplantation for secondary progressive multiple sclerosis: an exploratory cost-effectiveness analysis. - We conclude that HSCT could potentially achieve an acceptable level of cost-effectiveness. However, caution should be exercised as large, high-quality RCTs comparing HSCT versus mitoxantrone are necessary to validate these findings.Bone Marrow Transplantation advance online publication, 26 October 2009; doi:10.1038/bmt.2009.305. - Bone Marrow Transplant 2009 Oct 26. [Epub ahead of print] in PubMed

The effectiveness of choline citrate infusions monitored by lymphocyte transformation test (LTT) in multiple sclerosis. A new approach to the diagnosis and treatment of the disease. - Neuro Ebdocrinol Lett. 2009 Aug 26;30(3):331-334. [Epub ahead of print] in PubMed

Taking aim at novel vaccines market. - Hum Vaccin. 2009 Oct 4;5(10). [Epub ahead of print] in PubMed

Gene therapy in autoimmune diseases: Challenges and opportunities. - The recent success of Phase I/II clinical trials of gene therapy in rheumatoid arthritis and multiple sclerosis, development of cutting edge technology in target identification, as well as gene delivery systems have now set the stage for a more thorough and vigorous pace in the near future to advance this exciting field. - Autoimmun Rev. 2009 Oct 24. [Epub ahead of print] in PubMed

Autoimmune diseases induced by biological agents A double-edged sword? - In this review, we analyze the clinical characteristics and outcomes of autoimmune diseases developing after biological therapies through a baseline Medline search as one of the objectives of the BIOGEAS project, created by the Spanish Society of Internal Medicine. - Autoimmun Rev. 2009 Oct 22. [Epub ahead of print] in PubMed

Tuesday

 

Biogen's Tysabri Disclosure Policies Raise Questions

NEW YORK (Dow Jones)--Biogen Idec Inc.'s (BIIB) refusal to disclose new cases of a severe brain infection among multiple-sclerosis patients taking its Tysabri drug has raised questions about its disclosure policies.

The Cambridge, Mass., biotech company believes those developments aren't material news because the risk profile for developing progressive multifocal leukoencephalopathy, or PML, is well defined, and providing such information isn't beneficial for patients, physicians or investors unless that profile changes. As the company notes, the drug's label implies a risk rate of one in every thousand patients.

However, knowing the risk rate didn't prevent Biogen shares Friday from dropping more than 7% and shares of Elan Plc (ELN) ??? the drug's co-marketer ??? from falling almost 18% when the number of confirmed PML cases since its 2006 relaunch jumped to 23 from 13.

Some investors and analysts argue that Tysabri's significant role as the key growth driver for the companies makes any such developments vital in making a decision in investing in either company, and should be disclosed accordingly.

"It is hard to understand how they wouldn't have deemed it necessary to communicate such material information as soon as it was available to them," Geoffrey Porges, analyst with Sanford Bernstein, said. "I think the company will have to revisit its disclosure policies in light of this."

News of the sharp increase in PML cases didn't come from Biogen or Elan, neither of which have commented on the figure, but rather from U.S. and European regulators.

Although the companies consult with each other, Biogen takes the lead on releasing information on Tysabri related to MS. Elan's stock is more sensitive to related news because the drug is its biggest seller.

Biogen was keeping Wall Street updated on new cases until July, the third anniversary of Tysabri's relaunch, when it believed the risk profile would be clearer. It hasn't provided any information since that time.

"We are confident we are in full compliance with all disclosure requirements," Biogen spokeswoman Naomi Aoki said.

While the company contends that the PML-related information doesn't help physicians or patients, Morgan Stanley analyst Steven Harr notes that Biogen's decision to stop reporting cases, just as evidence of accelerating risk was developing, may in fact cause increased concern.............

Aoki said the company uses "statistically acceptable measurement of risk" that incorporates the number of patients exposed along with their duration of use.

On a conference call last week, Biogen executives defended the rate, which "even in that third year beyond 24 months, is within the currently implied risk in the label" ......full story in The Wall Street Journal

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Europe to review risk of Biogen/Elan drug Tysabri

BOSTON, Oct. 23 (Reuters) - European regulators said they have begun a review of the multiple sclerosis drug Tysabri in light of 23 reports of a potentially deadly brain infection known as progressive multifocal leukoencephalopathy, or PML, since the drug has been on the market.

Tysabri is made by the U.S. biotechnology company Biogen Idec Inc (BIIB.O) and Elan Corp Plc (ELN.I) (ELN.N) of Ireland. It was temporarily withdrawn from the market in 2005 after being linked with PML. It was reintroduced with stricter safety warnings in July 2006.

The European Medicines Agency said it has initiated the review to discuss any additional measures necessary to ensure the safe use of Tysabri.

Biogen's shares fell 6 percent to $44.45 in early trading while shares of Elan fell nearly 17 percent to $5.36. (Reporting by Toni Clarke, editing by Gerald E. McCormick) ... story in Reuters UK

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Gentle Touch May Aid Multiple Sclerosis Patients

While gripping, lifting or manipulating an object such as drinking from a cup or placing a book on a shelf is usually easy for most, it can be challenging for those with neurological diseases such as multiple sclerosis or Parkinson's, or for people who had a stroke. For them, the tight gripping can cause fatigue, making everyday tasks difficult.

A team of University of Illinois at Chicago physical therapists report this month in the journal Neurorehabilitation and Neural Repair that persons with multiple sclerosis use excessive force when they are lifting objects. In an earlier finding reported in the journal Clinical Neurophysiology, they reported that regaining control and coordination may be as easy as applying a gentle touch to the affected hand from a finger of the opposite hand. .... full story in Medical News Today

 

Multiple Sclerosis Researchers To Meet In Boston To Design Largest-Ever Vitamin D Study

On Saturday, October 17, leading MS researchers from around the country will meet at the Hyatt Regency, Boston to evaluate the feasibility of conducting what would be the largest clinical study ever undertaken to explore the role that Vitamin D play in Multiple Sclerosis. The meeting will be led by Dr. Benjamin Greenberg, deputy director of the MS program and director of the new Transverse Myelitis and Neuromyelitis Optica Program at University of Texas Southwestern Medical Center, and is being organized under the auspices of the nonprofit organization Accelerated Cure Project for Multiple Sclerosis.

Vitamin D is of particular interest to MS physicians and researchers, since previous epidemiological and laboratory studies have produced strong evidence that low vitamin D levels may play a role in causing MS. The purpose of this meeting is to discuss the feasibility of designing a large-scale study around vitamin D supplementation to evaluate its potential effects early in the course of the disease. This study would also result in the banking of thousands of additional blood samples into the Accelerated Cure Project's MS sample and data repository for future use in understanding the causes and disease mechanisms of MS.

The Accelerated Cure Project for MS has spent the past three years building the world's largest shared multidisciplinary collection of biological samples and data from people with MS and other demyelinating diseases, as well as control subjects. In addition to supporting individual research efforts around the world with these samples, the Accelerated Cure Project is committed to orchestrating studies such as this one that it believes can "accelerate the cure by determining the cause. ....full story in Medical News Today

 

Possible New Underlying Cause Of MS Investigated By Neurologists

Neurologists at the University at Buffalo are beginning a research study that could overturn the prevailing wisdom on the cause of multiple sclerosis (MS).

The researchers will test the possibility that the symptoms of MS result from narrowing of the primary veins outside the skull, a condition called "chronic cerebrospinal venous insufficiency," or CCSVI. (For more details on the study, go to http://www.bnac.net/?page_id=496.) ....full story in Medical News Today

 

European Drug Agency To Weigh Risks/Benefits Of Tysabri -- Cites 23 Cases Of PML

Today the EMEA, the European equivalent of the U.S. Food and Drug Administration, released a statement indicating that one of its advisory committees was launching a review of the risks and benefits of Tysabri® (natalizumab, Biogen Idec and Elan Pharmaceuticals) in light of 23 confirmed cases of PML that it says have occurred since the drug has been on the market. PML (progressive multifocal leukoencephalopathy) is a viral infection of the brain that usually leads to death or severe disability. (This number of cases is still within the anticipated frequency of 1 in 1,000 indicated in the drug's labeling.)

Unlike the situation in the U.S, there is no unified risk management strategy in place across Europe for the administration of Tysabri. In the U.S., the drug is administered only to patients registered with the company's TOUCH program.

The National MS Society will follow the European panel's deliberations on the safety of Tysabri and any new thoughts they might have on balancing the risks and benefits of this therapy for people with MS. .... full story in Medical News Today

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26 New Research Projects Launched Totaling $9.2 Million To Propel Multiple Sclerosis Research

The National MS Society has just committed $9.2 million to launch 26 new MS research projects as part of its comprehensive research program and commitment to move research forward. This investment comes despite a challenging economic environ¬ment, and is the latest in the Society's relentless research effort to stop MS, restore function, and end this disease forever.

The new projects include a clinical trial testing a type of physical therapy to improve function in people with progressive MS, and a project searching for gene variations that may explain why MS affects more women than men. Read summaries of all these new projects.

There are FDA-approved drugs that can impact the underlying disease course in people with the more common forms of MS. However, none of these drugs can stop or cure the disease. The National MS Society funded basic research that helped lead to the development of each of these drugs, and continues to be a driving force of MS research. Read more about how far we've come in MS research. .... full story in Medical News Today

 

FDA Panel Endorses MS Drug that Improves Walking

WASHINGTON -- An FDA advisory panel has voted to recommend approval of an investigational drug to increase walking speed in patients with multiple sclerosis, despite an increased risk of seizures.

The Peripheral and Central Nervous System Drugs Advisory Committee voted 12 to 1 that Acorda Therapeutic's fampridine (Amaya) was effective, and 10 to 2, with one abstention, that the drug can be used safely.

However, fampridine has a dose-dependent connection to seizures, so the panel voted 12 to 1 that Acorda should test doses lower than the proposed 10 mg twice-daily dosage. .... full story in MedPage Today

 

What's new for Multiple Sclerosis in PubMed

Autologous haematopoietic stem cell transplantation for secondary progressive multiple sclerosis: an exploratory cost-effectiveness analysis. - We conclude that HSCT could potentially achieve an acceptable level of cost-effectiveness. However, caution should be exercised as large, high-quality RCTs comparing HSCT versus mitoxantrone are necessary to validate these findings. - Bone Marrow Transplantation advance online publication, 26 October 2009; doi:10.1038/bmt.2009.305. in PubMed

The effectiveness of choline citrate infusions monitored by lymphocyte transformation test (LTT) in multiple sclerosis. A new approach to the diagnosis and treatment of the disease. - Neuro Endocrinol Lett, 2009 Aug 26;30(3):331-334. [Epub ahead of print] in PubMed

Taking aim at novel vaccines market. - The World Vaccine Congress Washington 2009 was held in Chantilly, VA USA April 20-23(rd). The importance of collaboration among academic institutions, industries and philanthropic foundations for developing markets was also emphasized. - Hum Vaccin. 2009 Oct 4;5(10). [Epub ahead of print] in PubMed

Endogenous opioids regulate expression of experimental autoimmune encephalomyelitis: a new paradigm for the treatment of multiple sclerosis. - These results imply that endogenous opioids, evoked by treatment with LDN and acting in the rebound period from drug exposure, are inhibitory to the onset and progression of EAE, and suggest that clinical studies of LDN are merited in MS and possibly in other autoimmune disorders. - Exp Biol Med (Maywood). 2009 Nov;234(11):1383-92. in PubMed

Gene Therapy in Autoimmune Diseases: Challenges and Opportunities. - The recent success of Phase I/II clinical trials of gene therapy in rheumatoid arthritis and multiple sclerosis, development of cutting edge technology in target identification, as well as gene delivery systems have now set the stage for a more thorough and vigorous pace in the near future to advance this exciting field. - Autoimmun Rev. 2009 Oct 22. [Epub ahead of print] in PubMed

[Wilson's disease and multiple sclerosis :] - Although Wilson's disease and multiple sclerosis are known as distinct diseases with a completely different pathophysiology, symptoms and results of evoked potentials overlap, and they share a common historic background. Similarities and differences of both disorders are discussed. - Nervenarzt. 2009 Oct 23. [Epub ahead of print] in PubMed

Rituximab in patients with primary progressive multiple sclerosis: Results of a randomized double-blind placebo-controlled multicenter trial. - Although time to CDP between groups was not significant, overall subgroup analyses suggest selective B-cell depletion may affect disease progression in younger patients, particularly those with inflammatory lesions. - Ann Neurol 2009;66:460-471. in PubMed


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