Toronto Stock Exchange Symbol: MS
EDMONTON, Oct. 3 /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 U.S.
pivotal phase III MAESTRO-03 trial of dirucotide (MBP8298) in patients with
secondary progressive MS has completed a safety analysis and recommended that
the trial continue as per the protocol.
This was the third of several regularly scheduled reviews by the DSMB
that will occur over the duration of the trial. The purpose of the DSMB is to
provide objective, independent safety monitoring of the trial.
The MAESTRO-03 U.S. pivotal phase III clinical trial is a randomized,
double-blind study that has completed recruitment of approximately 510
patients at 68 clinical sites who will be administered either dirucotide
(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 BioMS Medical Corp.
BioMS Medical is a biotechnology company engaged in the development and
commercialization of novel therapeutic technologies. BioMS Medical's lead
technology, dirucotide (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. In December 2007,
BioMS entered into a licensing and development agreement granting Eli Lilly
and Company exclusive worldwide rights to dirucotide (MBP8298), in exchange
for an $87 million upfront payment, milestone payments and escalating
royalties on sales. For further information please visit our website at
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 satisfactory 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: