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news.BioMS has announced that the independent data safety monitoring board for the company's Phase II Mindset-01 trial of MBP8298 in patients with relapsing-remitting multiple sclerosis has completed a safety analysis and recommended that the trial continue as per the protocol.
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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.
The Mindset-01 Phase II, double-blind, placebo-controlled trial is designed to evaluate the safety and efficacy of MBP8298 (dirucotide) in patients with relapsing-remitting multiple sclerosis. The fifteen month trial is fully enrolled with 218 patients at 24 sites in six countries.
The objectives of the study are to demonstrate safety and efficacy of MBP8298 (dirucotide) versus placebo as measured by relapse rate, MRI activity and disease progression.