�BioMS Medical Corp. (TSX:
MS), a leading developer in the treatment of multiple sclerosis (MS),
proclaimed 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 tryout 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 lag analysis included patients from the number one 200 to complete
MAESTRO-01 and assessed the likelihood of the study arrival its basal
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 1000000 milestone defrayment to BioMS as region of the terms of the
licensing and collaboration agreement.
"We are very encouraged by the safety board's testimonial," 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 footstep closer to our goal of bringing this crucial therapy
to multiple induration patients."
"We are pleased by the results of the meantime analysis and look forward
to last efficacy and safety information from this trial following year," aforementioned 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 prominent
underserved universe with late stage MS."
About MAESTRO-01
Dirucotide (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
intentional to value the safety and efficaciousness of dirucotide (MBP8298) in
patients with secondary progressive MS. The study is being conducted at 47
sites crossways Canada and nine countries in Europe and includes 611 patients
being administered either dirucotide (MBP8298) or placebo intravenously
every sextet months for a period of deuce years. The primary clinical endpoint
for the tribulation is defined as a statistically and clinically significant
increase in the time to patterned 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 will be assessed separately as an exploratory arm of the
like study.
About Dirucotide (MBP8298)
Dirucotide (MBP8298) is a synthetic peptide that consists of 17 amino group
acids having a successiveness identical to that of a part of human myelin
introductory 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 skittish 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 represent 65 to 75 pct of all MS patients.
The drug's apparent mechanism of activeness is the induction or restoration
of immunological leeway with regard to ongoing immune attack as a
result of high doses of peptide periodically delivered intravenously. The
potential benefit of the drug for any case-by-case patient is therefore
expected to be related to the persona this peptide plays in that patient's
immune system. The degree of immunomodulation achieved will depend on the
kinship 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
medial time to disease progression for basketball team years (versus placebo) in
progressive MS patients with HLA types DR2 and/or DR4. Thus, dirucotide
(MBP8298), if sanctioned, has the potential to be used as a tailored therapy
for patients genetically determined to verbalize the allow HLA
molecules.
About Multiple Sclerosis
Multiple sclerosis (MS) is thought to affect as many as 2.5 million
masses worldwide, including approximately 75,000 in Canada, four hundred,000 in the
United States and more than 500,000 in Europe. It is a disease that affects
more women than hands, with onset typically occurring between 20 and 50 years
of age. MS is caused by hurt to myeline, the protective sheath encompassing
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 walk and palsy. Approximately
40 percent of all MS patients have the secondary progressive cast 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 intervention of multiple
sclerosis and is organism 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 to boot 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 sole worldwide
rights to dirucotide (MBP8298), in exchange for an $87 million upfront
payment, milestone payments and escalating royalties on sales. For farther
information please visit our website at http://www.biomsmedical.com.
This press release may contain modern statements, which
reflect the Company's stream expectation regarding future events. These
forward-looking statements involve risks and uncertainties that may causa
actual results, events or developments to be materially different from any
future results, events or developments expressed or implied by such
innovative 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 regulative approval process and other risks detailed from
clip to sentence in the Company's ongoing quarterly and annual reporting.
Certain of the assumptions made in preparing innovative statements
include but ar not limited to the following: that MBP8298 will continue to
demonstrate a satisfactory refuge profile in ongoing and future clinical
trials; and that BioMS Medical Corp. will finish the several clinical
trials within the timelines communicated in this release. We undertake no
obligation to publicly update or revise any modern statements,
whether as a result of new data, future events or otherwise.
BioMS Medical Corp.
http://www.biomsmedical.com
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