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Mr. Kevin Giese reports
DIRUCOTIDE DOES NOT MEET PRIMARY ENDPOINT IN PHASE III MAESTRO-01 TRIAL IN SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS
BioMS Medical Corp. and Eli Lilly and Co.'s joint drug project, dirucotide, did not meet the primary end point 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 end points 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 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 enrolment 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 chief executive officer 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."
We seek Safe Harbor.
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