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news.The Data Safety Monitoring Board has reviewed data from BioMS Medical's ongoing MAESTRO-03 US pivotal Phase III clinical trial of MBP8298 for the treatment of secondary progressive multiple sclerosis and recommended that the trial continue.
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This was the first of several regularly scheduled reviews by the Data Safety Monitoring Board (DSMB) that will occur over the duration of the trial. The purpose of the DSMB is to provide objective, independent safety monitoring of the trial.
The MAESTRO-03 trial is a randomized, double-blind study enrolling approximately 510 patients at more than 60 clinical sites who will be administered either MBP8298 or placebo intravenously every six months for a period of two years.
The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the expanded disability status scale, in patients with HLA-DR2 and/or HLA-DR4 immune response genes (up to 75% of all multiple sclerosis patients are HLA-DR2 and/or HLA-DR4 positive).