FDA CLEARS BIOMS MEDICAL FOR PHASE III MULTIPLE SCLEROSIS.
"The clearance to proceed with a phase III trial in the U.S. is a significant step towards bringing MBP8298 to the worldwide market," said Kevin Giese, president and CEO of BioMS Medical. "There are approximately 400,000 Americans with MS and close to 50% of patients have secondary progressive MS. Between the U.S. initiative and the on-going pivotal phase III trial in Canada and Europe, we are successfully executing our global development plan for MBP8298."
The IND allows the commencement of a pivotal phase III secondary progressive MS clinical trial in the US and has been granted on the basis of satisfying FDA criteria regarding preclinical, chemistry, manufacturing and safety data from the completed and ongoing clinical studies for MBP8298.
MAESTRO-03 Phase III US Trial The pivotal phase III clinical trial in the US, named MAESTRO-03 (A Double-blind, Placebo Controlled Multi-center Study to Evaluate the Efficacy and Safety of MBP8298 in subjects with Secondary Progressive Multiple Sclerosis), will be evaluating MBP8298 for the treatment of secondary progressive multiple sclerosis (SPMS). The trial is a randomized, double-blind study enrolling approximately 510 patients 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 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.
MAESTRO-01 Trial The MAESTRO-01 pivotal phase II/III, multi-center, double-blind, placebo-controlled trial is currently being conducted at more than 50 sites across Canada and Europe and will enroll approximately 550 patients who will be administered either MBP8298 or placebo intravenously every six months for a period of two years. The trial is designed to evaluate the safety and efficacy of MBP8298 in patients with secondary progressive MS. 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. Time to disease progression in patients with other HLA-DR types will be assessed separately as an exploratory arm of the same study.
To date the trial has successfully passed six safety reviews by its independent Data Safety Monitoring Board.
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 over 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. 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 it has two pivotal phase III clinical trials for SPMS patients, MAESTRO-01 in Canada and Europe and MAESTRO-03 in the United States. It additionally has a Phase II MINDSET-01 trial in Europe for RRMS patients.
For more information, visit http://www.biomsmedical.com or call 780/413-7152.
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|Date:||Mar 1, 2007|
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