Friday, biotechnology company BioMS Medical Corp. (MS.TO) announced that the MINDSET-01 study, an exploratory mid-stage clinical trial evaluating dirucotide in patients with relapsing-remitting multiple sclerosis, or MS, failed to meet primary endpoints, annualized relapse rate or associated secondary MRI endpoints.
The MINDSET-01 study was a fifteen month, phase II, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of dirucotide in patients with relapsing-remitting MS.
The trial enrolled 218 patients at 24 sites in 6 European countries, with eligible patients randomized on a equal 1:1 basis to receive a total of three single intravenous doses of either drug or placebo at 0, 3 and 9 months. In addition, it was designed to additionally have a 12 month active treatment open label extension period which will provide further safety and efficacy data.
Dirucotide is being investigated for the potential treatment of MS, an autoimmune disease caused by immune attack against normal components of the central nervous system. The drug's proposed mechanism of action is the induction or restoration of immunological tolerance with respect to ongoing immune attack as a result of high doses of peptide periodically delivered intravenously.
The drug is being evaluated in two phase III clinical trials for Secondary Progressive MS patients, MAESTRO-01 in Canada and Europe and MAESTRO-03 in the United States. Results from the Canadian and European MAESTRO-01 trial are expected in the second half of 2009.
BioMS said that the company and its partner Eli Lilly & Company would continue to analyze the results of the exploratory phase II trial. Under the terms of the licensing agreement with Lilly, no milestone payment was associated with the trial.
It was in December 2007 that BioMS entered into a licensing and development agreement granting Eli Lilly and Company exclusive worldwide rights to dirucotide in exchange for an $87 million upfront payment, milestone payments and escalating royalties on sales.
MS ended Thursday's trading at C$3.43 on the Toronto Stock Exchange.
For comments and feedback contact: editorial@rttnews.com
June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.