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-03The 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
SclerosisMultiple 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
http://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 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.
http://www.biomsmedical.com