To: keokalani'nui who wrote (258 ) 1/14/2003 10:46:59 PM From: keokalani'nui Respond to of 824 From Co. PR, initiation of P2:Medicure Inc. (CDNX:MPH) is pleased to announce that it has received U.S. Food and Drug Administration (FDA) approval to carry out a Phase II multi-center clinical trial of MC-1 in high-risk cardiovascular patients undergoing elective angioplasty. The trial is designed to evaluate the cardioprotective effect of MC-1 against damage caused by ischemia and ischemic reperfusion experienced by heart disease patients undergoing angioplasty. The Phase II trial, a placebo controlled single blind feasibility study called MEND-1 for 'MC-1 to Eliminate Necrosis and Damage', will be carried out under the direction of Dr. James E. Tcheng MD, F.A.C.C. of the Duke University Medical Center. Dr. Tcheng is an internationally recognized clinician, scientist and research innovator in the areas of coronary intervention, platelet GP IIb/IIIa inhibitors, anti thrombin therapy and cardiology outcomes. The trial will enroll up to 100 high-risk patients scheduled for elective percutaneous coronary intervention by angioplasty at sites in the U.S. and Canada. In addition to Duke's participation as a recruiting site, the study will be managed by the Duke Clinical Research Institute (DCRI), Durham, North Carolina, a recognized leader in cardiovascular clinical trials, clinical drug research and the evaluation of novel therapeutics. The primary endpoint of the trial is infarct size (area of the heart that is damaged) during the procedure as determined by the release of the cardiac enzyme CK-MB over 24 hours following the angioplasty. Signs of myocardial ischemia will be followed over 24 hours by continuous EKG monitoring. The composite clinical endpoint of death, nonfatal myocardial infarct, new or worsening heart failure, or recurrent ischemia will finally be determined at 30 days after the procedure. I am going with 'flake' until the March presentation.