INDIANAPOLIS and EDMONTON--28 Jul--PRNewswire-AsiaNet/InfoQuest
Eli Lilly and Company (NYSE: LLY) and BioMS Medical Corp. (TSX: MS) today announced that dirucotide did not meet the primary endpoint of delaying disease progression, as measured by the Expanded Disability Status Scale (EDSS), during the two-year MAESTRO-01 Phase III trial in patients with secondary progressive
The data also showed that dirucotide was generally well tolerated. There were no unexpected safety or tolerability issues. The most common side effect reported was injection site reaction. More details of the MAESTRO-01 study results are expected to be presented at a medical conference later this year.
Lilly and BioMS also announced they would discontinue ongoing clinical trials – including MAESTRO-02 and MAESTRO-03 – and review the available data from these studies. MAESTRO-02 is an open-label follow-on study to MAESTRO-01.
MAESTRO-03 is a 510-patient U.S. Phase III clinical trial designed to evaluate dirucotide for the treatment of SPMS that completed enrollment in August 2008. Lilly and BioMS will inform regulatory agencies and provide instructions to investigators outlining the process for discontinuing the studies. Patients
“The MAESTRO-01 study was well designed and executed, and we believe these data, while disappointing, are very instructive for us and for the larger MS community,” said John Hayes, vice president of Lilly Research Laboratories. “We look forward to further conversations with BioMS Medical about this project.”
BioMS Medical Webcast
Participants may listen to a discussion of the outcome of the MAESTRO-01 study by Kevin Giese, President and CEO of BioMS Medical. The audio webcast is accessible through the Company’s web site at www.biomsmedical.com .
About MAESTRO-01
MAESTRO-01 was a multi-center, double-blind, placebo-controlled trial designed to evaluate the safety and efficacy of dirucotide in patients with SPMS. The study was conducted in Canada and nine countries in Europe and included 612 patients being administered either dirucotide or placebo intravenously every six months for a period of two years.
The primary clinical endpoint for the trial was defined as a statistically significant increase in the time to progression of the disease, as measured by the EDSS, in patients with HLA-DR2 and/or HLA-DR4 immune response genes. It is estimated that up to 70% of all multiple sclerosis patients are HLA-DR2 and/or
About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic, progressive, often disabling disease that attacks the central nervous system(ii). MS is caused by damage to myelin, the protective sheath surrounding nerve fibers in the central nervous system, resulting in disrupted nerve impulses traveling to and from the brain and spinal cord(iii). Symptoms of MS may include vision problems, loss of balance, numbness, difficulty walking and paralysis(iii, iv).
MS is thought to affect as many as 2.5 million people worldwide, including approximately 400,000 in the United States(v). It is a disease that affects more women than men, with onset typically occurring between 20 and 50 years of age(v).
Approximately 30-40 percent of all MS patients have the secondary progressive form of the disease(vi), in which irreversible disability accumulates more steadily, with or without relapses(vii). There are few
About Lilly
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com .
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, is for the treatment of multiple sclerosis. In December 2007, BioMS entered into a licensing and development agreement granting Eli Lilly and Company exclusive worldwide rights to dirucotide in exchange for an upfront payment, milestone payments and escalating royalties on sales. For further information please visit our website at www.biomsmedical.com.
(i) Wucherpfennig KW, Weiner HL, Hafler DA. T-cell recognition of myelin
(ii) Ransohoff, R.M. Natalizumab for Multiple Sclerosis. New England
(iii) National Multiple Sclerosis Society. “Symptoms.” Available at
(iv) National Multiple Sclerosis Society. “What is MS?” Available at
(v) National Multiple Sclerosis Society. “Who gets MS? Patterns in the
(vi) Markowitz, C. Dirucotide (MBP8298) for the treatment of multiple
(vii) National Multiple Sclerosis Society. “Four Disease Courses of MS:
(viii) Multiple Sclerosis Society. “Secondary Progressive Multiple
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SOURCE: Eli Lilly and Company
CONTACT: Tony Hesby or Ryan Giese of BioMS Medical Corp.,
Office: +1-780-413-7152,
Fax: +1-780-408-3040,
E-mail: [email protected];
or David Shaffer,
Eli Lilly and Company,
Office: +1-317-651-3710,
Mobile: +1-317-614-5106,
E-mail: [email protected]
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--Distributed by AsiaNet ( www.asianetnews.net )--
Eli Lilly and Company (NYSE: LLY) and BioMS Medical Corp. (TSX: MS) today announced that dirucotide did not meet the primary endpoint of delaying disease progression, as measured by the Expanded Disability Status Scale (EDSS), during the two-year MAESTRO-01 Phase III trial in patients with secondary progressive multiple sclerosis (SPMS). In addition, there were no statistically significant differences between dirucotide and placebo on the secondary endpoints of the study. The data also showed