BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple
sclerosis (MS), announced that the independent Drug Safety Monitoring Board
(DSMB) for the MAESTRO-01 trial has conducted the scheduled interim analysis of
efficacy and safety and has recommended that the trial continue to completion.
MAESTRO-01 is the pivotal phase II/III Canadian and European study of dirucotide
(MBP8298) in patients with secondary progressive MS.
The interim analysis
included patients from the first 200 to complete MAESTRO-01 and assessed the
likelihood of the study reaching its primary endpoint at the end of the trial in
MS patients with the target HLA-DR2 and/or HLA-DR4 immune response genes. The
DSMB analysis also included a scheduled review of safety
information.
Based on the DSMB decision, Eli Lilly and Company has agreed
to provide the $10 million milestone payment to BioMS as part of the terms of
the licensing and collaboration agreement.
"We are very encouraged by the
safety board's recommendation," said Kevin Giese, President and CEO of BioMS
Medical. "This positive review is an important milestone for BioMS and our
partner, Eli Lilly and Company, and moves us one step closer to our goal of
bringing this important therapy to multiple sclerosis patients."
"We are
pleased by the results of the interim analysis and look forward to final
efficacy and safety data from this trial next year," said Dr. Mark Freedman,
Professor of Neurology at the University of Ottawa and Director of the MS
Research Clinic at the Ottawa Hospital. "If successful, this novel therapy
administered only twice per year, could help a large underserved population with
late stage MS."
About MAESTRO-01Dirucotide (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 States.
-- MINDSET-01: A phase II trial for
relapsing-remitting MS (RRMS) patients in Europe.
MAESTRO-01 is a
multi-center, double-blind, placebo-controlled trial designed to evaluate the
safety and efficacy of dirucotide (MBP8298) in patients with secondary
progressive MS. The study is being conducted at 47 sites across Canada and nine
countries in Europe and includes 611 patients being 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. Time to disease
progression in patients with other HLA-DR types will be assessed separately as
an exploratory arm of the same study.
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.
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, 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
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
