Medicure to start phase 3 study for MC-1 in cardiovascular surgeries

By Elaine Rigoli

Tampa, Fla., April 12 - Medicure, Inc. said it has plans to proceed with a single confirmatory phase 3 study to gain approval for MC-1 in the reduction of cardiovascular events in patients undergoing coronary artery bypass graft surgery.

MC-1, a small molecule that may protect heart muscle cells, has received a fast-track designation from the Food and Drug Administration, according to a news release.

Based on an end-of-phase 2 meeting with the FDA, Medicure plans to use a composite of cardiovascular death and non-fatal myocardial infarction at post-operative day 30 as the primary endpoint for the phase 3 study, expected to begin in the second half of calendar 2006.

Since cardiomyocytes are essential for normal heart function and do not regenerate themselves following an ischemic event, MC-1's cardioprotective properties have demonstrated potential for minimizing ischemic damage and maintaining proper heart function, the release said.

Based in Winnipeg, Manitoba, Medicure is a cardiovascular drug-discovery and development company focused on developing effective therapeutics for unmet needs in the field of cardiovascular medicine.

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