EDMONTON, June 5 /PRNewswire-FirstCall/ - BioMS Medical Corp , a leading developer of products for the treatment of multiple sclerosis (MS), today announced that the first patients have been enrolled in MAESTRO-03, its U.S. pivotal phase III clinical trial of MBP8298, a proprietary synthetic peptide for the treatment of multiple sclerosis. The randomized, double-blind study is enrolling approximately 510 secondary progressive MS patients at approximately 60 sites across the U.S. who will be administered either MBP8298 or placebo intravenously every six months for a period of two years.
“This is an important milestone in our strategy to commercialize MBP8298 on a global basis,” said Kevin Giese, President and CEO of BioMS Medical. “The U.S. represents nearly half of the MS market and a successful outcome to this trial would put BioMS in a strong position to capture a significant portion of this and other major MS markets.”
The primary clinical endpoint for the MAESTRO-03 trial is defined as a statistically significant time to disease progression 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.
MBP8298 is being assessed in two additional ongoing trials: - MAESTRO-01 is a pivotal phase III trial being conducted 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. - MINDSET-01 is 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 approximately 215 patients.
Patients who are interested to learn more about these trials should visit: http://www.biomsmedical.com/maestro_03.asp
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 otherwise “tolerant” of such common 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.
About Multiple Sclerosis
Multiple sclerosis (MS) is thought to affect as many as 2.5 million people worldwide, including approximately 75,000 in Canada, 400,000 in the United States and more than 450,000 in Western Europe. MS is a progressive disease of the central nervous system, characterized initially by episodes of paralysis, blindness, sensory disturbances and cognitive impairment. Almost half of all MS patients have the secondary progressive form of the disease.
About BioMS Medical Corp.
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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 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 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.
BioMS Medical Corp.
CONTACT: Tony Hesby, Ryan Giese, Corporate Communications, BioMS MedicalCorp., (780) 413-7152, (780) 408-3040 Fax, E-mail: rgiese@biomsmedical.com,Internet: www.biomsmedical.com; James Smith, Investor Relations, (416)815-0700 ext. 229, (416) 815-0080 Fax, E-mail: jsmith@equicomgroup.com
