Toronto Stock Exchange Symbol: MS
EDMONTON, Sept. 4 /CNW/ - BioMS Medical Corp. (TSX: MS), a leading
developer in the treatment of multiple sclerosis (MS), today announced that
the Food and Drug Administration (FDA) of the United States has granted fast
track designation for the Company's lead drug, dirucotide (MBP8298), for the
treatment of secondary progressive MS (SPMS). Dirucotide (MBP8298) is
currently being evaluated in a U.S. pivotal phase III trial, named MAESTRO-03,
at 68 sites with approximately 510 patients.
Fast track designation is an FDA status reserved for products that are
intended to treat a serious or life-threatening condition and that demonstrate
the potential to address unmet medical needs for that condition. Fast track
designation can potentially facilitate development and expedite the review
"Our receipt of fast track designation for dirucotide in the U.S. is a
significant milestone for both BioMS Medical and the MS community," said
Kevin Giese, President and CEO of BioMS Medical. "Based on previous clinical
results, we believe dirucotide is well-positioned to become a first-in-class
treatment for secondary progressive MS patients, a large patient population
with very limited treatment options."
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 Dirucotide (MBP8298)
Dirucotide (MBP8298) is a synthetic peptide that consists of 17 amino
acids having a sequence identical to that of a portion of human myelin basic
protein (MBP). Dirucotide is being developed for the potential treatment of
multiple sclerosis (MS), an autoimmune disease caused by immune attack against
normal components of the central nervous system. The sequence of dirucotide is
associated with the autoimmune process in MS patients with certain immune
response genes (HLA types DR2 and/or DR4); MS patients having these genes
represent 65 to 75 percent of all MS patients.
The drug's apparent mechanism of action is the induction or restoration
of immunological tolerance with respect to ongoing immune attack as a result
of high doses of peptide periodically delivered intravenously. The potential
benefit of the drug for any individual patient is therefore expected to be
related to the role this peptide plays in that patient's immune system. The
degree of immunomodulation achieved will depend on the relationship among the
peptide, HLA molecules and T cells.
The results of phase II and long-term follow-up treatment of MS patients
with MBP8298 (dirucotide), published in 2006 in the European Journal of
Neurology (EJN), showed that MBP8298 (dirucotide) safely delayed median time
to disease progression for five years (versus placebo) in progressive MS
patients with HLA types DR2 and/or DR4. Thus, dirucotide (MBP8298), if
approved, has the potential to be used as a tailored therapy for patients
genetically determined to express the appropriate HLA molecules.
Dirucotide (MBP8298) is being studied in four late-stage clinical trials:
- MAESTRO-01: A pivotal phase II/III trial for secondary progressive MS
(SPMS) patients in Canada and Europe.
- MAESTRO-02: An open-label safety extension study to MAESTRO-01.
- MAESTRO-03: A pivotal phase III trial for SPMS patients in the United
- MINDSET-01: A phase II trial for relapsing-remitting MS (RRMS)
patients in Europe.
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; James Smith, Investor
Relations, (416) 815-0700 ext. 229, (416) 815-0080 Fax, E-mail: