Eli Lilly and Company and BioMS Medical Corp 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 US 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 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."

Maestro-01 was a multi-center, double-blind, placebo-controlled trial designed to evaluate the safety and efficacy of dirucotide in patients with SPMS.

BioMS Medical is a biotechnology company engaged in the development and commercialization of novel therapeutic technologies.