Latest News

Multiple Sclerosis Disease Activity Reduced After Taking Oral Fumarate

October 25th 2008

An article published in The Lancet reports successful results from a phase II trial for oral fumarate (BG00012). The drug was found to significantly reduce disease activity linked to relapsing-remitting multiple sclerosis (RRMS) that was detected by Magnetic Resonance Imaging (MRI). A phase III trial is underway and the researchers are awaiting the results. Read more here

Source: Medical News Today

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Cancer drug could prove lifeline for MS sufferers

October 24th 2008

LIFE sciences company BTG has this week revealed that a well-known cancer treatment could also have a dramatic impact on controlling the advancement of the debilitating condition multiple sclerosis (MS). Read more here

Source: Medical Laboratory World

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Results of Landmark BENEFIT trial: Five year data confirm that early treatment with Betaferon® at first sign of disease can delay progression to MS

September 20 2008

BENEFIT is first and only prospectively planned study to show long lasting benefit of early treatment. New data confirm that early initiation of Betaferon® (interferon beta-1b) treatment in patients with a first event suggestive of multiple sclerosis (MS) significantly delays the onset of clinically-definite MS (CDMS) by 37 percent (p=0.003) and McDonald MS by 45 percent (p<0.0001) over five years compared to delayed treatment. The results confirm a continued benefit of initiating treatment with Betaferon shortly after the first event.

“The BENEFIT five-year results are the first and only prospective data to confirm a continuous benefit over five years when treatment is initiated shortly after the earliest sign of MS,” said Dr. Mark Freedman, Professor of Neurology at the University of Ottawa and investigator of the study. “These results confirm that treatment with Betaferon after the first MS event or attack can reduce the risk of developing MS over five years compared to delayed treatment.” Read more here

Source: BAYNEWS

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Acorda Therapeutics Presents Additional Data from Second Positive Phase 3 Study of Fampridine-SR

September 20 2008

Acorda Therapeutics, Inc. today announced additional data from its second Phase 3 clinical trial of Fampridine-SR (MS-F204) on walking ability in people with MS at the late breaking news session of the World Congress on Treatment and Research in MS, being held in Montreal, Canada. Previously, the Company announced the trial met its primary endpoint with a significantly greater proportion of people taking Fampridine-SR having a consistent improvement in walking speed compared to people taking placebo (42.9% vs. 9.3%), as measured by the Timed 25-Foot Walk (p less than 0.001). The study also met its secondary outcome measure, leg strength, showing a statistically significant increase in the Fampridine-SR Timed Walk responders compared to placebo (p = 0.028).

New findings and information presented at the meeting from the study included:

The response rate for Fampridine-SR treated patients was higher than placebo across all MS subtypes. Response rates for the four major MS subtypes in the study were: relapsing-remitting: 37.2%; secondary-progressive: 45.9%; primary-progressive: 50.0%; and progressive-remitting: 40.0%.
Response rates were similar between study participants who were being treated with immunomodulators and those who were not.
The Fampridine-SR treated group showed improvement in the Ashworth Score (a physician-reported measure of spasticity), which was significant in an unplanned analysis.
Baseline demographic and disease characteristics of study participants were also presented, including the percentage of Fampridine-SR treated patients with each subtype of MS (relapsing-remitting: 35.8%; primary-progressive: 8.3%; secondary-progressive: 51.7%; and progressive-relapsing: 4.2%) and the mean duration of disease in Fampridine-SR treatment patients (14.43 years).

"People with MS often cite walking disability as one of the most challenging aspects of their disease, and there are no therapies currently indicated for improving walking in MS," said Andrew Goodman, M.D., Director of the Multiple Sclerosis Center at the University of Rochester, who presented the data. "The results of this study, which were consistent with the first Phase 3 Fampridine-SR trial, show that Fampridine-SR may provide benefit to people with walking difficulties." Read more here

Source: Acorda Therapeutics

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TYSABRI® DEMONSTRATES SUSTAINED IMPROVEMENT IN FUNCTIONAL OUTCOMES IN MULTIPLE SCLEROSIS PATIENTS ACCORDING TO NEW POST-HOC ANALYSIS

September 19 2008

Biogen Idec and Elan Corporation announced that a post-hoc analysis showed TYSABRI® (natalizumab) treatment increases the probability of achieving sustained improvement in physical disability over two years when compared to placebo. This post-hoc analysis provides the first evidence that TYSABRI is associated with a significant improvement in functional outcome, rather than only slowing or preventing progression of disability, in those living with relapsing multiple sclerosis (MS). These findings were derived from a subset analysis of the Phase III AFFIRM trial.

"These results show that TYSABRI treated patients are significantly more likely to experience a sustained improvement in disability compared to placebo patients. This finding from a post-hoc analysis of the pivotal AFFIRM trial supports both the earlier findings from the AFFIRM trial that TYSABRI is associated with an improvement in quality of life as well as anecdotal evidence of recovery of function in some patients." said Frederick E. Munschauer, MD, Smith Professor and Chair, Department of Neurology, State University of New York at Buffalo. "While, like TYSABRI, other therapies have shown a slowing of progression in disability, this analysis represents the first evidence supporting a sustained improvement in function associated with an approved disease modifying therapy." Read more here

Source: Biogen Idec Website

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Merck Serono initiates a Phase III trial to evaluate the therapeutic effects of cladribine in patients at risk of developing MS.

September 18 2008

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today the initiation of a Phase III trial to evaluate the therapeutic effects of its proprietary oral formulation of cladribine (cladribine tablets) in patients at risk of developing multiple sclerosis (MS).

The trial, called ORACLE MS (ORAl CLadribine in Early MS) will evaluate the safety and efficacy of two dosage regimens of cladribine tablets versus placebo in the treatment of patients who have experienced a first clinical event suggestive of MS. Cladribine tablets are currently also being evaluated in a fully enrolled Phase III pivotal trial – the CLARITY1 study – for treatment of relapsing forms of MS. As announced in January 2007, CLARITY was the first pivotal trial among all Phase III oral compounds in development for MS to complete enrollment. Cladribine tablets have been granted a fast track designation by the US Food and Drug Administration.

“There is increasing evidence supporting the initiation of treatment with a disease-modifying drug in patients who have experienced a first clinical event suggestive of multiple sclerosis, an initial stage of the disease when clinical manifestations are not necessarily pronounced but where the potential exists for irreversible neurological damage to take place,” said Dr. Thomas Leist, Associate Professor of Neurology and Director of the Comprehensive MS Center at Thomas Jefferson University, Philadelphia, PA, and an investigator in the ORACLE MS study. “The ORACLE MS study will evaluate the effectiveness and safety of cladribine tablets in preventing conversion to definite multiple sclerosis.” Read more here

Source: Merck Serono Website

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Laquinimod Demonstrated Significant and Sustained Impact on Multiple Sclerosis Disease Activity

September 18 2008

New data from the extension phase of oral laquinimod in relapsing-remitting multiple sclerosis (RRMS) demonstrated a significant reduction in the mean number of gadolinium-enhancing (GdE) lesions in both patients who switched from placebo to laquinimod and patients who continued with their initial laquinimod dose.

In RRMS patients who switched from placebo to laquinimod, 52 percent reduction in the mean number of GdE lesions was observed (p<0.0007). The reduction was significant for both patients switching to high-dose (p<0.009) and low-dose laquinimod (p<0.03). In addition, the proportion of patients who switched to active treatment from placebo, and remained enhancing lesion-free, increased from 31 percent to 47 percent (p<0.012), further reinforcing the efficacy of laquinimod on magnetic resonance imaging (MRI) measured disease activity.

Patients initially treated with 0.6mg/day and 0.3mg/day during the double-blind trial remained on the same dose during the 36-week extension phase. An additional significant reduction in the mean number of GdE lesions was also observed in these patients (n=94, p=0.0062 and n=80, p=0.0013, respectively), a high proportion of which remained completely free of GdE lesions, demonstrating the sustained effect of laquinimod on MRI disease activity.

"These latest data show the rapid onset and sustainability of laquinimod efficacy in MS patients," said Giancarlo Comi, M.D., University Vita-Salute San Raffaele, Scientific Institute San Raffaele, Milan, Italy, principal investigator of the study. "Just as exciting is the fact that, with increased number of patients exposed to laquinimod, we found no new risks or safety issues. This reinforces earlier results demonstrating the laquinimod safety profile. The MS community looks forward to future data as we continue enrolling patients in the laquinimod Phase III clinical program."

These new data from the extension study build upon the initial 36-week, Phase IIb study results published in The Lancet*, which demonstrated that once-daily, oral 0.6mg laquinimod significantly reduced MRI disease activity by a median of 60 percent, compared to placebo, and was well tolerated. Read more here

*Lancet 2008; 371:2085-92

Source: Teva Website

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BioMS wins FDA fast track designation for multiple sclerosis drug

5th September 2008

BioMS Medical, a biotechnology company involved in the treatment of multiple sclerosis, has announced that the FDA has granted fast track designation for the company's lead drug, dirucotide, for the treatment of secondary progressive multiple sclerosis.

The MAESTRO-03 U.S. pivotal phase III clinical trial is a randomized, double-blind study that has completed recruitment of approximately 510 patients at 68 clinical sites who will be administered either dirucotide (MBP8298) or placebo intravenously every six months for a period of two years.

There are no trial sites in Australia.

Source: BioMS Website

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GW's cannabis-based drug shows long-term efficacy

8th September 2008

GW Pharmaceuticals announced that a study of its cannabis-based pain killer Sativex has shown long-term efficacy in the treatment of neuropathic pain due to multiple sclerosis.It is the first time that the long-term effectiveness of the drug had been demonstrated in a so-called placebo-controlled study, where it is tested against a dummy drug.

The news is also significant for the company because it bolsters hopes that it might gain approval for the drug as a treatment for spasticity associated with multiple sclerosis, because the trial is very similar to a late-stage trial that has been running at the request of regulators.

Stephen Wright, GW's R&D Director, said in a statement: "It is encouraging to note that if the difference between Sativex and placebo achieved in the results today are replicated in the ongoing Phase III MS spasticity study, this Phase III study will meet its objectives."

This study is due to report results in the first quarter of 2009 with a regulatory submission planned for the first half of 2009.

There are no trial sites in Australia.

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Opexa Therapeutics and Myelin Repair Foundation Partner on Novel Multiple Sclerosis Research Program

9th September 2008

Collaboration to Identify Therapeutically Relevant Biomarkers and Offer Key Insight for Further Clinical Development of Tovaxin®

Opexa Therapeutics, a company dedicated to the development of patient-specific cellular therapies for the treatment of autoimmune diseases such as multiple sclerosis (MS) and diabetes, today announced the establishment of a novel MS research partnership with the Myelin Repair Foundation, Inc. (MRF). As part of this collaboration, Opexa and the MRF will work to identify therapeutically relevant biomarkers in MS that may provide important insight to support the continued development of Tovaxin®, Opexa’s T-cell vaccine currently in Phase IIb clinical testing in MS patients. In addition, biomarkers identified as part of the research program may also assist in guiding the discovery and development of novel diagnostics and treatments for MS.

There are no trial sites in Australia.

Source: Business Wire (09/09/08)