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BioMS Medicals's Pivotal Multiple Sclerosis Trial Receives Positive Interim Safety Analysis |
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06 Apr 2007 |
Announced that the independent Data Safety Monitoring Board (DSMB) for the Company's pivotal phase II/III MAESTRO-01 trial of MBP8298 in patients with secondary progressive MS has completed a planned interim safety analysis and recommended that the trial continue as per the protocol.
EDMONTON, Canada | Apr 05, 2007 | BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced that the independent Data Safety Monitoring Board (DSMB) for the Company's pivotal phase II/III MAESTRO-01 trial of MBP8298 in patients with secondary progressive MS has completed a planned interim safety analysis and recommended that the trial continue as per the protocol.
This interim analysis was based upon an assessment of the first 100 patients enrolled in the 550 patient study who had completed twelve months of treatment. In-depth safety data, including extensive MRI scans, were collected for this patient group and reviewed by the DSMB.
“Multiple sclerosis patients currently lack a safe and effective treatment to slow or halt disease progression,” said Kevin Giese , President and CEO of BioMS Medical. “This positive recommendation represents important progress toward the completion of our pivotal study, and provides us with further confidence in MBP8298's safety profile and its prospects of achieving clinical success.”
This is the first of two planned interim analysis in respect of MAESTRO-01. The next interim analysis will look at both safety and efficacy in the first 200 patients who have completed 24 months of the clinical trial, and is targeted for mid-2008.
About MAESTRO-01 Trial
The MAESTRO-01 pivotal phase II/III, multi-center, double-blind, placebo-controlled trial is designed to evaluate the safety and efficacy of MBP8298 in patients with secondary progressive MS. The study is being conducted at 48 sites across Canada and Europe and includes approximately 550 patients being 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. Time to disease progression in patients with other HLA-DR types will be assessed separately as an exploratory arm of the same study.
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.
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 of approximately 550 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 up to 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 enrolling up to 215 patients.
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.
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 .
SOURCE: BioMS Medical Corp |
