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news.BioMS Medical, a biotechnology company, has reported that the independent Data Safety Monitoring Board for the company's US pivotal Phase III Maestro-03 trial of dirucotide in patients with secondary progressive multiple sclerosis has completed a safety analysis and recommended that the trial continue as per the protocol.
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The Maestro-03 US pivotal Phase III clinical trial is a randomized, double-blind study that has completed recruitment of approximately 510 patients at 67 clinical sites who will be administered either dirucotide 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 (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes.
This was the fourth 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.