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BioMS Medical Announces 2008 Year End Results
Date:3/17/2009

its primary endpoint at the end of the trial. Based on the DSMB decision, Eli Lilly and Company (Lilly) provided a US $10 million milestone payment to BioMS as part of the terms of the licensing and collaboration agreement. BioMS anticipates MAESTRO-01 will be completed in 2009 with results from the trial expected in the second half of this year. - MAESTRO-02: Eligible patients who have successfully completed MAESTRO-01 may choose to receive dirucotide on an un-blinded basis in this open-label follow-on study. To date, approximately 95% of the eligible patients who have successfully completed the MAESTRO-01 trial have enrolled in this follow-on study. - MAESTRO-03: Enrollment was initiated in June, 2007 and completed on August 1, 2008 for this pivotal U.S. phase III trial of approximately 510 SPMS patients at 67 sites across the U.S. To date, the DSMB has conducted three reviews of the data from this trial and recommended it continue. The next DSMB review is expected to take place in the second quarter of fiscal 2009. - MINDSET-01: MINDSET-01 was a randomized, double-blind study that recruited 218 relapsing-remitting MS patients at 24 trial sites in six countries across Europe. BioMS recently announced that the top line results of this exploratory study did not meet its primary endpoint of effecting annualized relapse rate or associated secondary magnetic resonance imaging (MRI) endpoints. Dirucotide did meet certain secondary endpoints related to the progression of the disease, including mean change from baseline in the EDSS and the MS Functional Composite (MSFC) score. Changes in EDSS and MSFC are primary and secondary outcomes in the ongoing phase III SP
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