BioMS Medical Corp. (TSX:
MS), a leading developer in the treatment of multiple sclerosis (MS),
announced that it has completed patient recruitment in its phase III
clinical trial of MBP8298 (dirucotide) for the treatment of secondary
progressive MS (SPMS). The trial, named MAESTRO-03, includes approximately
510 patients, and is being conducted at 68 trial sites in the U.S.
"We have had great success in recruiting patients into the trial, which
is a testament to the promise of our approach and the efforts of our
investigators," said Mr. Kevin Giese, President and CEO. "Since initiating
this trial in June 2007 we have been delighted by the enthusiasm of the
patients and clinical groups participating across the U.S."
MBP8298 (dirucotide) is currently being developed in three late-stage
clinical trials:
1. MAESTRO-01: A pivotal phase II/III trial for secondary progressive MS
(SPMS) patients in Canada and Europe.
2. MAESTRO-03: A pivotal phase III trial for SPMS patients in the United
States.
3. MINDSET-01: A phase II trial for relapsing-remitting MS (RRMS)
patients in Europe.
About MAESTRO-03
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 MBP8298
(dirucotide) 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 MBP8298 (dirucotide)
MBP8298 (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). MBP8298 (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 MBP8298 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 apparent mechanism of action of MBP8298 (dirucotide) is the
induction or restoration of immunological tolerance with respect to ongoing
immune attack as a result of high doses of peptide delivered periodically
by the intravenous route. The potential benefit of MBP8298 (dirucotide) 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, MBP8298
(dirucotide) has the potential to be used as a tailored therapy for
patients genetically determined to express the appropriate HLA molecules.
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 500,000 in Europe. It is a disease that affects
more women than men, with onset typically occurring between 20 and 50 years
of age. MS is caused by damage to myelin, the protective sheath surrounding
nerve fibers in the central nervous system, which interferes with messages
from the brain to the body. Symptoms of MS may include vision problems,
loss of balance, numbness, difficulty walking and paralysis. Approximately
40 percent 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 (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 MBP8298 (dirucotide) in exchange for an $87 million upfront
payment, milestone payments and escalating royalties on sales. For further
information please visit our website at biomsmedical.
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.
BioMS Medical Corp.
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