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Toronto Stock Exchange Symbol: MS
EDMONTON, Nov. 6 /PRNewswire-FirstCall/ - BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced financial and operational results for the third quarter ended September 30, 2008. BioMS Medical, in partnership with Eli Lilly and Company (Lilly), is developing dirucotide (MBP8298), a drug for the treatment of MS undergoing pivotal trials in Canada, Europe and the U.S.
"The third quarter saw positive developments in the dirucotide development plan, with completion of the interim analysis resulting in a significant milestone payment from our partner Lilly," said Kevin Giese, President and CEO of BioMS Medical. "Dirucotide was also granted fast track designation by the U.S. FDA, another important achievement which could potentially accelerate the development and review process for this important MS drug."
Currently, BioMS is conducting three clinical trials and one open-label
follow-on trial for dirucotide (MBP8298):
- MAESTRO-01: A randomized, double-blind pivotal phase II/III trial in
Canada and Europe evaluating dirucotide (MBP8298) for the treatment
of secondary progressive MS (SPMS). The study has completed full
recruitment of 611 patients at 47 trial sites in 9 countries. To
date, there have been nine positive safety reviews from the Data
Safety Monitoring Board (DSMB). Full analysis of this trial is
expected in the second half of 2009.
- MAESTRO-02: An open-label follow-on study to the MAESTRO-01 pivotal
trial. Eligible patients who have successfully completed the blinded,
placebo controlled MAESTRO-01 trial may choose to receive dirucotide
(MBP8298) on an un-blinded basis. To date, approximately 95% of
patients enrolled in MAESTRO-01 have proceeded to MAESTRO-02.
- MAESTRO-03: A U.S. pivotal phase III trial evaluatin
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