Toronto Stock Exchange Symbol: MS
EDMONTON, Feb. 27 /CNW/ - BioMS Medical Corp (TSX: MS), a leading
developer of products for the treatment of multiple sclerosis (MS), today
announced that it has initiated MAESTRO-02, the open-label follow-on portion
to its MAESTRO-01 pivotal phase II/III clinical trial of MBP8298 for the
treatment of secondary progressive MS.
Eligible patients who have successfully completed the blinded, placebo
controlled MAESTRO-01 trial may choose to receive MBP8298 on an un-blinded
basis in MAESTRO-02 regardless of whether they were previously on placebo or
drug. The trial will primarily evaluate the long-term safety of MBP8298.
"Now that the first patients who participated in our MAESTRO-01 pivotal
trial have completed the study, we are pleased to offer MBP8298 on an
open-label basis," said Kevin Giese, President and CEO of BioMS Medical. "We
believe MBP8298 has the potential to become the only safe and effective first
line therapy for the treatment of secondary progressive MS. While MAESTRO-01
was designed to evaluate the safety and efficacy of MBP8298, MAESTRO-02 will
provide additional important long-term safety and efficacy data to support
About late-stage clinical trials for MBP8298:
BioMS recently announced that patient recruitment has been completed in
the MAESTRO-01 trial. This trial includes approximately 550 patients at 48
trial sites in 10 countries. The Company remains on track to receive interim
data in mid-2008.
Patients are 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.
MBP8298 is being studied in two additional late-stage clinical trials:
- MAESTRO-03: A pivotal phase III U.S. trial of similar design to
MAESTRO-01, evaluating MBP8298 for the treatment of secondary
progressive MS. The trial is a randomized, double-blind study
enrolling approximately 510 patients that will be initiated in 2007.
- 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 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 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 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.
For further information:
For further information: Tony Hesby, Ryan Giese, Corporate
Communications, BioMS Medical Corp., (780) 413-7152, (780) 408-3040 Fax,
E-mail: firstname.lastname@example.org, Internet: www.biomsmedical.com; James Smith,
Investor Relations, (416) 815-0700 ext. 229, (416) 815-0080 Fax, E-mail:
email@example.com; Barry Mire, Investor Relations, (514) 939-3989,