BioMS Medical Completes Patient Recruitment In MAESTRO-01 Pivotal Phase II/III Multiple Sclerosis Trial Of MBP8298

Main Category: Multiple Sclerosis
Also Included In: Neurology / Neuroscience;  Clinical Trials / Drug Trials
Article Date: 23 Jan 2007 - 0:00 PDT

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BioMS Medical Corp (TSX: MS), a leading developer of products for the treatment of multiple sclerosis (MS), today announced that it has completed patient recruitment in its pivotal phase II/III clinical trial of MBP8298 for the treatment of secondary progressive MS. The trial, named MAESTRO-01, will include approximately 550 patients at 48 trial sites in 10 countries. The Company remains on track to receive interim data in mid-2008 from the first 200 patients enrolled, when they have completed the 24 months of treatment.

"We are pleased to have reached this major milestone in this very important study," said Kevin Giese, President and CEO of BioMS Medical. "It brings us one step closer to our objective of offering patients a safe and effective first line therapy for the treatment of secondary progressive multiple sclerosis, with the convenience of two I.V. doses per year."

"The clinical investigators, study site personnel and BioMS Medical's drug development team all have done an outstanding job of recruiting patients and conducting this trial at the highest quality standards," said Dr. Kjell Stenberg, Chief Operating Officer of BioMS Medical. "The need and enthusiasm for this project in the MS community is well recognized and the results of this pivotal study are eagerly awaited."

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 will include 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.

To date the trial has successfully passed six safety reviews by its independent Data Safety Monitoring Board.

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 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 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 500,000 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 being developed globally for the treatment of multiple sclerosis (MS). It has 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 is also being evaluated in a Phase II MINDSET-01 trial in Europe for Relapsing Remitting MS patients. For further information please visit our website at http://www.biomsmedical.com.

This news release may contain certain forward-looking statements that reflect the current views and/or expectations of BioMS Medical with respect to its performance, business and future events. Such statements are subject to a number of risks, uncertainties and assumptions. Actual results and events may vary significantly.

BioMS Medical Corp.
http://www.biomsmedical.com

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