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Toronto Stock Exchange Symbol: MS
EDMONTON, May 11 /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 first quarter, ended March 31, 2009.
"We remain on track to obtain the results from MAESTRO-01, the first of our two pivotal trials evaluating dirucotide in patients with secondary progressive multiple sclerosis, in the second half of 2009," said Kevin Giese, President and CEO of BioMS Medical. "We have demonstrated in previous trials that dirucotide has shown to be well tolerated and has the capacity to slow the progression of disease in certain genetically pre-disposed MS patients. If our pivotal trials confirm these results, we believe dirucotide could represent the first drug with blockbuster potential for the treatment of secondary progressive multiple sclerosis."
Currently, BioMS is conducting two pivotal clinical trials and one open-label follow-on trial of dirucotide for the treatment of secondary progressive MS (SPMS):
- MAESTRO-01: On January 22, 2007, BioMS announced that this pivotal
phase III trial, being conducted in Canada and Western Europe, had
completed full recruitment of 611 SPMS patients at 47 trial sites in
ten countries. The primary clinical endpoint for MAESTRO-01 (and
MAESTRO-03) is defined as a statistically and clinically significant
increase in the time to progression of the disease as measured by the
Expanded Disability Status Scale (EDSS), in patients with HLA-DR2
and/or HLA-DR4 immune response genes.
On April 21, 2009 the DSMB conducted a scheduled safety analysis and
recommended that the trial continue to completion. To date, there have
been ten positive safety reviews from the Data Safety Monitoring Board
(DSMB) and this was the final scheduled review by
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