Another hurdle cleared...
BioMS Medical's pivotal multiple sclerosis trial receives positive interim safety analysis
Thursday April 5 -- CNW -- BioMS Medical today announced that the independent Data Safety Monitoring Board (DSMB) for the Company's pivotal phase II/III MAESTRO-01 trial of MBP8298 in patients with secondary progressive MS has completed a planned interim safety analysis and recommended that the trial continue as per the protocol.
This interim analysis was based upon an assessment of the first 100 patients enrolled in the 550 patient study who had completed twelve months of treatment. In-depth safety data, including extensive MRI scans, were collected for this patient group and reviewed by the DSMB.
"Multiple sclerosis patients currently lack a safe and effective treatment to slow or halt disease progression," said Kevin Giese, President and CEO of BioMS Medical. "This positive recommendation represents important progress toward the completion of our pivotal study, and provides us with further confidence in MBP8298's safety profile and its prospects of achieving clinical success."
This is the first of two planned interim analysis in respect of MAESTRO-01. The next interim analysis will look at both safety and efficacy in the first 200 patients who have completed 24 months of the clinical trial, and is targeted for mid-2008.
About MAESTRO-01 Trial
The MAESTRO-01 pivotal phase II/III, multi-center, double-blind, placebo-controlled trial is designed to evaluate the safety and efficacy of MBP8298 in patients with secondary progressive MS. The study is being conducted at 48 sites across Canada and Europe and includes approximately 550 patients being 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 (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes. Time to disease progression in patients with other HLA-DR types will be assessed separately as an exploratory arm of the same study.
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