Toronto Stock Exchange Symbol: MS
EDMONTON, Jan. 30 /PRNewswire-FirstCall/ - BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced results from MINDSET-01, an exploratory phase II clinical trial evaluating dirucotide in patients with relapsing-remitting MS. The lead clinical development program for dirucotide is for secondary progressive MS where it is being evaluated in two ongoing phase III trials in the United States, Canada and Europe, with results from the Canadian and European MAESTRO-01 trial expected in the second half of 2009.
The results of the MINDSET-01 study showed that dirucotide did not meet its primary endpoint, annualized relapse rate or associated secondary MRI endpoints. Dirucotide did meet certain secondary endpoints related to the progression of the disease, including mean change from baseline in the Expanded Disability Status Scale (EDSS) and the Multiple Sclerosis Functional Composite (MSFC) score. The EDSS is a method of quantifying disability in MS, while the MSFC evaluates additional functional parameters. Measuring changes in EDSS and MSFC are primary and secondary outcomes in the ongoing phase III secondary progressive MS trials.
The data also showed that dirucotide was generally well tolerated. The most common side effects reported were redness and burning sensation at the injection site. No patients withdrew due to adverse events.
BioMS and its partner Eli Lilly & Company (Lilly) will continue to analyze the results of this exploratory phase II trial. Under the terms of the licensing agreement with Lilly, no milestone payment was associated with this trial.
"We are encouraged that dirucotide has demonstrated an effect on certain clinical measures of disease progression, this time in the earlier form of the disease," said Kevin Giese, President and CEO of BioMS Medical. "Dirucotide was developed as a potential treatment f
|SOURCE BioMS Medical Corp.|
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