Edmonton, Alberta, June 5, 2007 - BioMS Medical Corp (TSX: MS), a leading developer of products for the treatment of multiple sclerosis (MS), today announced that the first patients have been enrolled in MAESTRO-03, its U.S. pivotal phase III clinical trial of MBP8298, a proprietary synthetic peptide for the treatment of multiple sclerosis. The randomized, double-blind study is enrolling approximately 510 secondary progressive MS patients at approximately 60 sites across the U.S. who will be administered either MBP8298 or placebo intravenously every six months for a period of two years.
“This is an important milestone in our strategy to commercialize MBP8298 on a global basis,” said Kevin Giese, President and CEO of BioMS Medical. “The U.S. represents nearly half of the MS market and a successful outcome to this trial would put BioMS in a strong position to capture a significant portion of this and other major MS markets.”
The primary clinical endpoint for the MAESTRO-03 trial is defined as a statistically significant time to disease progression as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes. Up to 75% of all MS patients are HLA-DR2 and/or HLA-DR4 positive.
MBP8298 is being assessed in two additional ongoing trials:
• MAESTRO-01 is a pivotal phase III trial being conducted in Canada and Western Europe evaluating MBP8298 for the treatment of secondary progressive multiple sclerosis (SPMS). The trial is a randomized, double-blind study and is fully recruited with 611 patients.
• MINDSET-01 is a phase II trial evaluating MBP8298 for the treatment of relapsing-remitting multiple sclerosis (RRMS). The trial is a randomized, double-blind study and is fully recruited with approximately 215 patients.
Patients who are interested to learn more about these trials should visit: http://www.biomsmedical.com/maestro_03.asp
About MBP8298 - Novel Mechanism of Action
In MS patients, the body's immune system inappropriately attacks the myelin coating around the nerves in the brain and spinal column, whereas healthy people are otherwise “tolerant” of such common body components. The proposed mechanism of action of MBP8298 is, by design, to re-introduce such a state of “tolerance” to a critical portion of the nerve's Myelin Basic Protein that is an immunological site of attack in many MS patients. This is accomplished by the I.V. injection of MBP8298 every six months.
Phase II and long-term follow-up treatment of MS patients with MBP8298, recently published in the European Journal of Neurology showed that MBP8298 safely delayed the median time to disease progression for five years in progressive MS patients with HLA-DR2 or HLA-DR4 immune response genes.
About BioMS Medical Corp.
BioMS Medical is a biotechnology company engaged in the development and commercialization of novel therapeutic technologies. BioMS Medical's lead technology, MBP8298, is for the treatment of multiple sclerosis and is being evaluated in two pivotal phase III clinical trials for secondary progressive MS patients, MAESTRO-01 in Canada and Europe and MAESTRO-03 in the United States . It additionally is being evaluated for relapsing remitting MS patients in a Phase II trial in Europe entitled MINDSET-01. For further information please visit our website at www.biomsmedical.com .
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