Dirucotide Does Not Meet Primary Endpoint in Phase III MAESTRO-01 Trial in Secondary Progressive Multiple Sclerosis
INDIANAPOLIS and EDMONTON, Alberta, July 27 /PRNewswire-FirstCall/ — 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 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 involved in studies who have questions should contact their study investigator.
“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.”
“We are obviously disappointed by this result and will be working closely with our clinical team to evaluate these data and the available data from MAESTRO-02 and MAESTRO-03 to determine our next steps,” said Kevin Giese, President and CEO of BioMS Medical. “We are fortunate to have suitable resources in place to remain flexible to pursue whatever options emerge once we understand these results more fully.”
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.
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 HLA-DR4 positive(i). The EDSS is the standard for measuring impairment in MS.
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 treatment options available for these patients(viii).
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.
This press release may contain forward-looking statements, which reflect the current expectation of Lilly and BioMS 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. For further discussion of these and other risks and uncertainties, see Lilly’s filings with the United States Securities and Exchange Commission and BioMS’ filings with SEDAR. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
(i) Wucherpfennig KW, Weiner HL, Hafler DA. T-cell recognition of myelin basic protein. Immunology Today, 1991; 12: 277-282.
(ii) Ransohoff, R.M. Natalizumab for Multiple Sclerosis. New England Journal of Medicine, 2007 Jun; 356; 25: 2622.
(iii) National Multiple Sclerosis Society. “Symptoms.” Available at http://www.nationalmssociety.org/about-multiple-sclerosis/symptoms/index.aspx. Accessed on 7.20.09
(iv) National Multiple Sclerosis Society. “What is MS?” Available at http://www.nationalmssociety.org/chapters/MOS/programs–services/LearnAboutMS/what-is-ms/index.aspx. Accessed on 7.20.09
(v) National Multiple Sclerosis Society. “Who gets MS? Patterns in the Distribution of MS.” Available at http://www.nationalmssociety.org/about-multiple-sclerosis/who-gets-ms/index.aspx. Accessed on 7.20.09
(vi) Markowitz, C. Dirucotide (MBP8298) for the treatment of multiple sclerosis. Therapy, 2008. 5(5): 1.
(vii) National Multiple Sclerosis Society. “Four Disease Courses of MS: Secondary-Progressive MS (SPMS).” Available at http://www.nationalmssociety.org/about-multiple-sclerosis/what-is-ms/four-disease-courses-of-MS/index.aspx. Accessed on 7.20.09
(viii) Multiple Sclerosis Society. “Secondary Progressive Multiple Sclerosis: How do you know when you have become
secondary progressive?” Available at http://www.mssociety.org.uk/doc_store/SecondaryProgressive.pdf. Accessed on 7.20.09
SOURCE Eli Lilly and Company