BioMS stocks plunge on failed trial

BioMS Medical shares plunged more than 30 percent today on the news that its phase II trial MINDSET-01--designed to evaluate dirucotide in patients with relapsing-remitting multiple sclerosis--did not meet its primary endpoint, in terms of the annualized relapse rate, or its associated secondary MRI endpoints.

However, the results did demonstrate that the drug is effective in delaying the progression of the disease. Data also showed that dirucotide was generally well tolerated and no patients withdrew due to adverse events, the company said. The 15-month study included 218 patients at 24 sites in six European countries.

"We are encouraged that dirucotide has demonstrated an effect on certain clinical measures of disease progression, this time in the earlier form of the disease," said Kevin Giese, President and CEO of BioMS Medical. "Dirucotide was developed as a potential treatment for patients with progressive MS and we believe that these results are consistent with the nature of the therapy, and what is understood about dirucotide's method of action."

Dirucotide is also being evaluated in phase III clinical trials for secondary progressive MS in the US, Canada and Europe, with results from the Canadian and European MAESTRO-01 trial expected later this year.

BiosMS is developing dirucotide in partnership with Eli Lilly, but per their licensing agreement, no milestone payment was associated with this trial.

- here's the BioMS release
- read the RTTNews article
- check out the National Post article

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