Toronto Stock Exchange Symbol: MS
EDMONTON, April 5 /CNW/ - 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
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.
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
For further information:
For further information: Tony Hesby, Ryan Giese, Corporate
Communications, BioMS Medical Corp., (780) 413-7152, (780) 408-3040 Fax,
E-mail: email@example.com, Internet: www.biomsmedical.com; James Smith,
Investor Relations, (416) 815-0700 ext. 229, (416) 815-0080 Fax, E-mail: