Toronto Stock Exchange Symbol: MS
EDMONTON, Nov. 12 /PRNewswire-FirstCall/ - BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced that more than 133 patients have been enrolled in its MAESTRO-03 U.S. pivotal phase III clinical trial of MBP8298 for the treatment of secondary progressive multiple sclerosis (SPMS). An interim safety and efficacy analysis will be performed on data from the first 133 patients enrolled when they have completed 24 months of the clinical trial.
"There has been overwhelming enthusiasm and support from the MS community for our U.S. Phase III trial," said Kevin Giese, President and CEO of BioMS Medical. "With the ramp-up in the initiation of participating clinical sites and patient recruitment we are on track to complete enrollment in the first half of 2008."
The MAESTRO-03 U.S. pivotal phase III clinical trial is a randomized, double-blind study enrolling approximately 510 patients at more than 60 clinical sites who will be administered either MBP8298 or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial 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 (up to 75% of all MS patients are HLA-DR2 and/or HLA-DR4 positive).
About MBP8298 - Novel Mechanism of Action
In MS patients, the body's immune system inappropriately attacks the myelin coating around the nerves in the brain and spinal column, whereas healthy people are "tolerant" of such normal body components. The proposed mechanism of action of MBP8298 is, by design, to re-introduce such a state of "tolerance" to a critical portion of the nerve's Myelin Basic Protein that is an immunological site of attack in many MS patients. This is accomplished by the I.V. injection of MBP8298 every six months.
Phase II and long-term follow-up treatment of MS patients with MBP8298, recently published in the European Journal of Neurology showed that MBP8298 safely delayed the median time to disease progression for five years in progressive MS patients with HLA-DR2 or HLA-DR4 immune response genes.
MBP8298 is being developed in three late-stage clinical trials:
- MAESTRO-01: A pivotal phase III trial in Canada and Western Europe
evaluating MBP8298 for the treatment of secondary progressive
multiple sclerosis (SPMS). The trial is a randomized, double-blind
study and is fully recruited with 611 patients.
- MAESTRO-03: A pivotal phase III U.S. trial evaluating MBP8298 for the
treatment of SPMS. The trial is a randomized, double-blind study
enrolling approximately 510 patients.
- MINDSET-01: A phase II trial evaluating MBP8298 for the treatment of
relapsing remitting multiple sclerosis (RRMS). The trial is a
randomized, double-blind study and is fully recruited with 218
About BioMS Medical Corp.
BioMS Medical is a biotechnology company engaged in the development and commercialization of novel therapeutic technologies. BioMS Medical's lead technology, MBP8298, is for the treatment of multiple sclerosis and is being evaluated in two pivotal phase III clinical trials for secondary progressive MS patients, MAESTRO-01 in Canada and Europe and MAESTRO-03 in the United States. It additionally is being evaluated for relapsing remitting MS patients in a Phase II trial in Europe entitled MINDSET-01. For further information please visit our website at http://www.biomsmedical.com.
This press release may contain forward-looking statements, which reflect the Company's current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting. Certain of the assumptions made in preparing forward-looking statements include but are not limited to the following: that MBP8298 will continue to demonstrate a satisfactory safety profile in ongoing and future clinical trials; and that BioMS Medical Corp. will complete the respective clinical trials within the timelines communicated in this release. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
|SOURCE BioMS Medical Corp.|
Copyright©2007 PR Newswire.
All rights reserved