MPH-T NR today 79m at 1.78
Medicure plans MC-1 phase III study
2006-04-12 08:26 ET - News Release
Mr. Derek Reimer reports
MEDICURE REPORTS ON MEND-CABG END OF PHASE II MEETING WITH THE FDA
Based on the positive phase II MEND-CABG study and a recent end of phase II meeting with the U.S. Food and Drug Administration, Medicure Inc. plans to proceed with a single confirmatory phase III study to gain approval for MC-1 in the reduction of cardiovascular events in patients undergoing coronary artery bypass graft (CABG) surgery. MC-1 has received a fast-track designation from the FDA.
Based on the end of phase II meeting, Medicure plans to use a composite of cardiovascular death and non-fatal myocardial infarction (primary definition peak CK-MB greater than or equal to 100 nanograms per millilitre) at postoperative day 30 as the primary end point for the phase III study. Initiation of this study is targeted for the second half of calendar 2006.
"We are extremely pleased with the outcome of the end of phase II meeting with the FDA. A single confirmatory study provides Medicure the most efficient and affordable path for MC-1's phase III development, and is a valuable asset in our partnership negotiations," commented Medicure's president and chief executive officer, Albert D. Friesen, PhD. "MC-1 has the opportunity to be the first product indicated to reduce cardiovascular events associated with ischemia and/or ischemic reperfusion injury in CABG patients, targeting a significant unmet medical need. We look forward to working with the FDA in expediting the development of MC-1."
MC-1 is a small molecule that reduces the amount of damage to the heart following ischemia and/or ischemic reperfusion injury. Studies with MC-1 suggest that it does this by protecting cardiomyocytes (heart muscle cells). Since cardiomyocytes are essential for normal heart function and do not regenerate themselves following an ischemic event, their preservation is key to minimizing ischemic damage and maintaining proper heart function. MC-1's cardioprotective properties have been demonstrated in the phase II MEND-1 study in patients undergoing percutaneous coronary interventions and the phase II MEND-CABG study in patients undergoing CABG surgery.
We seek Safe Harbor.
AI
