Dirucotide Does Not Meet Primary Endpoint in Phase III MAESTRO-01 Trial In Secondary Progressive Multiple Sclerosis
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Medical Update Memo
July 29, 2009
Summary
INDIANAPOLIS, Indiana and EDMONTON, Alberta, July 27, 2009 – 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.
Details
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.
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. The EDSS is one of several scales used for measuring impairment in MS.
“It is disappointing that dirucotide has failed to improve the course of secondary progressive MS,” states Dr. Paul O’Connor, national scientific and clinical advisor for the MS Society of Canada. “The MS community is anxious for the development of an effective therapy that will treat the progressive forms of multiple sclerosis. It is important to remember however, that every study, even studies with negative outcomes, betters our understanding of the disease process. ”
The MS Society of Canada and its related MS Scientific Research Foundation continue to support research into the cause, management and cure that will end all forms of multiple sclerosis.
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Disclaimer
The Multiple Sclerosis Society of Canada is an independent, voluntary health
agency and does not approve, endorse or recommend any specific product or therapy,
but provides information to assist individuals in making their own decisions.
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