Toronto Stock Exchange Symbol: MS
- Milestone triggers $10 million payment from Eli Lilly and Company -
EDMONTON, Aug. 13 /PRNewswire-FirstCall/ - BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today 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."
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
- 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
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
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
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.
|SOURCE BioMS Medical Corp.|
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