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This was the fourth of several regularly scheduled reviews by the DSMBthat will occur over the duration of the trial. The purpose of the DSMB is toprovide objective, independent safety monitoring of the trial.
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MINDSET-01 Trial
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The MINDSET-01 phase II, double-blind, placebo-controlled trial isdesigned to evaluate the safety and efficacy of MBP8298 (dirucotide) inpatients with relapsing-remitting MS. The fifteen month trial is fullyenrolled with 218 patients at 24 sites in 6 countries. The objectives of thestudy are to demonstrate safety and efficacy of MBP8298 (dirucotide) versusplacebo as measured by relapse rate, MRI activity and disease progression.
About BioMS Medical Corp.
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BioMS Medical is a biotechnology company engaged in the development andcommercialization of novel therapeutic technologies. BioMS Medical's leadtechnology, MBP8298 (dirucotide), is for the treatment of multiple sclerosisand is being evaluated in two pivotal phase III clinical trials for secondaryprogressive MS patients, MAESTRO-01 in Canada and Europe and MAESTRO-03 in theUnited States. It additionally is being evaluated for relapsing remitting MSpatients in a Phase II trial in Europe entitled MINDSET-01. In December 2007,BioMS entered into a licensing and development agreement granting Eli Lillyand Company exclusive worldwide rights to MBP8298 (dirucotide) in exchange foran $87 million upfront payment, milestone payments and escalating royalties onsales. For further information please visit our website atwww.biomsmedical.com.
This press release may contain forward-looking statements, which reflectthe Company's current expectation regarding future events. Theseforward-looking statements involve risks and uncertainties that may causeactual results, events or developments to be materially different from anyfuture results, events or developments expressed or implied by suchforward-looking statements. Such factors include, but are not limited to,changing market conditions, the successful and timely completion of clinicalstudies, the establishment of corporate alliances, the impact of competitiveproducts and pricing, new product development, uncertainties related to theregulatory approval process and other risks detailed from time to time in theCompany's ongoing quarterly and annual reporting. Certain of the assumptionsmade in preparing forward-looking statements include but are not limited tothe following: that MBP8298 will continue to demonstrate a satisfactory safetyprofile in ongoing and future clinical trials; and that BioMS Medical Corp.will complete the respective clinical trials within the timelines communicatedin this release. We undertake no obligation to publicly update or revise anyforward-looking statements, whether as a result of new information, futureevents or otherwise.
SOURCE BioMS Medical Corp.
