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This was the second 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 in patients withrelapsing-remitting MS. The fifteen month trial is fully enrolled with 218patients at 24 sites in 6 countries. The objectives of the study are todemonstrate safety and efficacy of MBP8298 versus placebo as measured byrelapse 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, is for the treatment of multiple sclerosis and is beingevaluated in two pivotal phase III clinical trials for secondary progressiveMS patients, MAESTRO-01 in Canada and Europe and MAESTRO-03 in the UnitedStates. It additionally is being evaluated for relapsing remitting MS patientsin a Phase II trial in Europe entitled MINDSET-01. For further informationplease visit our website at www.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 safety profile inongoing and future clinical trials; and that BioMS Medical Corp. will completethe respective clinical trials within the timelines communicated in thisrelease. 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.