MBP8298 HOLDS PROMISE FOR PROGRESSIVE MS
Following the sixth meeting of the independent Data Safety Monitoring Board, (which provides objective, independent safety monitoring of clinical trials) BioMS has received a recommendation to continue its pivotal phase II/III clinical trial for MBP8298 for the treatment of secondary progressive MS.

This was the sixth of several regularly scheduled reviews by the Data Safety Monitoring Board. The pivotal phase II/III study is now ongoing at trial sites across Canada and Europe.

Results of the Phase II and long-term follow-up treatment of progressive MS patients with MBP8298, which were published in the European Journal of Neurology, show that MBP8298 safely delayed disease progression for five years in progressive MS patients with HLA-DR2 or HLA-DR4 immune response genes.

Treatment and follow-up in patients in this DR2 and DR4 responder group - who comprise up to 75% of MS patients - had a median time to disease progression of 78 months as compared to 18 months for patients who received placebo.

"Our data suggest that we can safely delay progression of MS in an identified responder group of patients for extended periods of time," said Ingrid Catz, co-inventor of the drug and co-author of the Phase II study. "Recognizing the high variability of the disease in MS patients, the clinical and mechanistic evidence gathered to date supports the rationale of targeting patients with the HLA-DR2 or HLA-DR4 immune response gene. The identification of this responder group will improve efficiency toward the achievement of objectives in future clinical trials with MBP8298, while the potential for clinical responses in patients with other HLA haplotypes is further explored."

MBP8298 is a synthetic Myelin Basic Protein peptide (MBP) comprised of 17 amino acids. Administered as an intravenous injection, five minutes or less in duration, every six months, the drug is expected to induce immunological tolerance specific to the injected antigen.

"MBP8298 appears to have a mechanism of action somewhat like glatiramer acetate (Copaxone)," explains MSF Medical Advisor Ben Thrower, M.D. "Copaxone was designed to look like myelin basic protein and works by shifting the immune system to a less inflammatory state. MBP8298 appears to work in a similar fashion."

While these results are positive, they must be confirmed in the ongoing Phase III trial. To learn more, visit http://www.biomsmedical.com.