Dirucotide Does Not Meet Primary Endpoint in Phase III MAESTRO-01 Trial in Secondary Progressive Multiple...( INDIANAPOLIS and EDMONTON Alber...),Health

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 b
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