BioMS Medical's phase III U.S. multiple sclerosis trial receives positive safety review from Data Safety Monitoring Board
Posted Nov 17 2009 10:20pm
April 14, 2009
EDMONTON, April 14 /CNW/ - BioMS Medical Corp. (TSX: MS - News ), a leading developer in the treatment of multiple sclerosis (MS), today announced that the independent Data Safety Monitoring Board (DSMB) for the Company's U.S. pivotal phase III MAESTRO-03 trial of dirucotide in patients with secondary progressive MS has completed a safety analysis and recommended that the trial continue as per the protocol.
This was the fourth of several regularly scheduled reviews by the 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.
About MAESTRO-03 ----------------
The MAESTRO-03 U.S. 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 (up to 70% of all MS patients are HLA-DR2 and/or HLA-DR4 positive).