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BioMS Medical initiates enrollment in pivotal U.S. phase III multiple sclerosis trial

Tuesday June 5 -- BioMS Medical 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.

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