Toronto Stock Exchange Symbol: MS
- Milestone triggers $10 million payment from Eli Lilly and Company -
EDMONTON, Aug. 13 /CNW/ - 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 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 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 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
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.
For further information:
For further information: Tony Hesby, Ryan Giese, Corporate
Communications, BioMS Medical Corp., (780) 413-7152, (780) 408-3040 Fax,
E-mail: firstname.lastname@example.org, Internet: www.biomsmedical.com; James Smith,
Investor Relations, (416) 815-0700 ext. 229, (416) 815-0080 Fax, E-mail: