Toronto Stock Exchange Symbol: MS
EDMONTON, Jan. 30 /CNW/ - BioMS Medical Corp. (TSX: MS), a leading
developer in the treatment of multiple sclerosis (MS), today announced results
from MINDSET-01, an exploratory phase II clinical trial evaluating dirucotide
in patients with relapsing-remitting MS. The lead clinical development program
for dirucotide is for secondary progressive MS where it is being evaluated in
two ongoing phase III trials in the United States, Canada and Europe, with
results from the Canadian and European MAESTRO-01 trial expected in the second
half of 2009.
The results of the MINDSET-01 study showed that dirucotide did not meet
its primary endpoint, annualized relapse rate or associated secondary MRI
endpoints. Dirucotide did meet certain secondary endpoints related to the
progression of the disease, including mean change from baseline in the
Expanded Disability Status Scale (EDSS) and the Multiple Sclerosis Functional
Composite (MSFC) score. The EDSS is a method of quantifying disability in MS,
while the MSFC evaluates additional functional parameters. Measuring changes
in EDSS and MSFC are primary and secondary outcomes in the ongoing phase III
secondary progressive MS trials.
The data also showed that dirucotide was generally well tolerated. The
most common side effects reported were redness and burning sensation at the
injection site. No patients withdrew due to adverse events.
BioMS and its partner Eli Lilly & Company (Lilly) will continue to
analyze the results of this exploratory phase II trial. Under the terms of the
licensing agreement with Lilly, no milestone payment was associated with this
"We are encouraged that dirucotide has demonstrated an effect on certain
clinical measures of disease progression, this time in the earlier form of the
disease," said Kevin Giese, President and CEO of BioMS Medical. "Dirucotide
was developed as a potential treatment for patients with progressive MS and we
believe that these results are consistent with the nature of the therapy, and
what is understood about dirucotide's method of action."
About MINDSET-01 Study
The MINDSET-01 study was a fifteen month, phase II, double-blind,
placebo-controlled trial designed to evaluate the efficacy and safety of
dirucotide in patients with relapsing-remitting MS. The trial enrolled 218
patients at 24 sites in 6 European countries, with eligible patients
randomized on a equal 1:1 basis to receive a total of three single intravenous
doses of either drug or placebo at 0, 3 and 9 months. The study enrolled
patients into two sub-groups: 154 patients testing positive for the HLA-DR2
and/or HLA-DR4 immune response gene; and 64 patients testing negative for the
HLA-DR2 and HLA-DR4 gene. The study was designed to additionally have a 12
month active treatment open label extension period which will provide further
safety and efficacy data.
BioMS is conducting ongoing pivotal clinical trials evaluating the ability
of dirucotide to affect disease progression in patients with secondary
- MAESTRO-01: A Canadian/European pivotal phase III trial evaluating
dirucotide for the treatment of secondary progressive MS (SPMS). The
study has completed full recruitment of 611 patients at 47 trial
sites in nine countries. To date, there have been nine positive
safety reviews from the Data Safety Monitoring Board (DSMB). Full
analysis of this trial is expected in the second half of 2009.
- MAESTRO-02: An open-label follow-on study to the MAESTRO-01 pivotal
trial. Eligible patients who have successfully completed the blinded,
placebo controlled MAESTRO-01 trial may choose to receive dirucotide
on an un-blinded basis in MAESTRO-02. Of patients who have
successfully completed MAESTRO-01 to date, approximately 95 percent
have entered the follow-on study.
- MAESTRO-03: A U.S. pivotal phase III trial evaluating dirucotide for
the treatment of SPMS. The trial is fully recruited with
approximately 510 patients enrolled at 68 sites across the U.S. To
date, the DSMB has conducted three reviews of the data from this
trial and has recommended it continue.
BioMS Medical management will host a conference call at 8:30 a.m. (EST)
on January 30, 2009 to discuss the MINDSET-01 trial. Participants may listen
via an audio web cast, accessible through the Company's website at
www.biomsmedical.com or via telephone. The telephone conference number is
416-644-3415 or toll-free at 800-732-9303.
Dirucotide 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 investigated 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 approximately 70 percent of all MS patients.
The drug's proposed 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 and
disease process. 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 dirucotide, published in 2006 in the European Journal of Neurology (EJN),
showed that dirucotide delayed median time to disease progression for five
years (versus placebo) in progressive MS patients with HLA types DR2 and/or
DR4, and generally well tolerated.
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, 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 in exchange for an $87
million upfront payment, milestone payments and escalating royalties on sales.
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This press release may contain forward-looking statements, which reflect
the Corporation'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
Corporation'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 dirucotide 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, Amanda Stadel, BioMS
Medical Corp., (780) 413-7152, (780) 408-3040 Fax, E-mail:
firstname.lastname@example.org, Internet: http://www.biomsmedical.com; James Smith,
Investor Relations, (416) 815-0700 ext. 229, (416) 815-0080 Fax, E-mail: