�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 efficaciousness
and refuge 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 lowly progressive MS.
The lag analysis included patients from the first 200 to complete
MAESTRO-01 and assessed the likelihood of the study reach its primary
endpoint at the terminal of the trial in MS patients with the target HLA-DR2
and/or HLA-DR4 immune reply genes. The DSMB analytic thinking 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 collaborationism agreement.
"We are identical encouraged by the safety board's good word," said
Kevin Giese, President and CEO of BioMS Medical. "This positive brushup is
an important milestone for BioMS and our partner, Eli Lilly and Company,
and moves us one stair closer to our goal of bringing this crucial therapy
to multiple sclerosis patients."
"We are proud of by the results of the lag analysis and look forwards
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 class, could help a large
underserved population with late stage MS."
About MAESTRO-01Dirucotide (MBP8298) is existence studied in four late-stage clinical trials: -- MAESTRO-01: A pivotal phase II/III tribulation for secondary progressive
MS (SPMS) patients in Canada and Europe.
-- MAESTRO-02: An open-label safety prolongation 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 efficaciousness of dirucotide (MBP8298) in
patients with secondary reformist 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-spot months for a period of deuce years. The primary clinical endpoint
for the trial is outlined as a statistically and clinically important
increase in the time to advance 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 volition be assessed separately as an exploratory arm of the
same study.
About Dirucotide (MBP8298) Dirucotide (MBP8298) is a synthetical peptide that consists of 17 amino
acids having a episode identical to that of a component part of human myelin
basic protein (MBP). Dirucotide is being developed for the potential
intervention 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 sure immune response genes (HLA types DR2 and/or DR4); MS
patients having these genes present 65 to 75 percent of all MS patients.
The drug's apparent mechanism of action is the induction or restoration
of immunological allowance with respect to ongoing immune flack 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 part this peptide plays in that patient's
immune organization. The degree of immunomodulation achieved will depend on the
relationship among the peptide, HLA molecules and T cells.
The results of form II and long-term followup treatment of MS
patients with MBP8298 (dirucotide), promulgated in 2006 in the European
Journal of Neurology (EJN), showed that MBP8298 (dirucotide) safely delayed
median time to disease progress for quint years (versus placebo) in
progressive MS patients with HLA types DR2 and/or DR4. Thus, dirucotide
(MBP8298), if sanctioned, has the potential to be victimized as a tailored therapy
for patients genetically determined to extract the set aside HLA
molecules.
About Multiple Sclerosis Multiple induration (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 work force, with onrush typically occurring between 20 and 50 years
of age. MS is caused by hurt to medulla, the protective sheath surrounding
nerve fibers in the central neural system, which interferes with messages
from the brain to the body. Symptoms of MS may admit vision problems,
loss of balance, numbness, difficulty walking and paralysis. Approximately
40 percent of all MS patients get the secondary progressive shape of the
disease.
About BioMS Medical Corp. BioMS Medical is a biotechnology company engaged in the development and
commercialisation of novel therapeutic technologies. BioMS Medical's lead
engineering, dirucotide (MBP8298), is for the discourse of multiple
sclerosis and is existence 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 gross sales. For farther
information please visit our website at http://www.biomsmedical.com.
This compress release whitethorn contain innovative statements, which
reflect the Company's stream expectation regarding future events. These
innovative statements involve risks and uncertainties that may cause
actual results, events or developments to be materially different from any
next results, events or developments expressed or implied by such
advanced statements. Such factors admit, but are not limited to,
ever-changing market conditions, the successful and timely completion of
clinical studies, the institution of corporate alliances, the impact of
competitive products and pricing, new product development, uncertainties
related to the regulative approval march and other risks detailed from
meter to time in the Company's ongoing quarterly and annual reporting.
Certain of the assumptions made in preparing modern statements
include but ar not limited to the following: that MBP8298 volition continue to
demonstrate a satisfactory safety profile in ongoing and future clinical
trials; and that BioMS Medical Corp. will make out the various clinical
trials within the timelines communicated in this release. We undertake no
obligation to publicly update or revise any advanced statements,
whether as a result of new information, future events or otherwise.
BioMS Medical Corp.
http://www.biomsmedical.com
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