Medicure Inc., a cardiovascular biotechnology company, has reported that patient enrollment has commenced in its multi-centre Phase II clinical trial to evaluate the cardioprotective effect of MC-1 against potential damage caused by ischemia and ischemic reperfusion frequently experienced by high risk heart disease patients undergoing angioplasty.
Angioplasty is a common cardiovascular intervention that, while generally beneficial in addressing an arterial narrowing or blockage, is associated with dangerous complications including arrhythmia, myocardial stunning, and ischemic heart damage. According to the American Heart Association some 686,000 angioplasty procedures were carried out in the United States alone in the year 2000.
The Phase II trial is a placebo controlled single blind feasibility study called MEND-1 for 'MC-1 to Eliminate Necrosis and Damage'. As previously announced, 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 under the direction of Principal Investigator, Dr. James E. Tcheng MD, F.A.C.C.
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. 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 angioplasty. Secondary endpoints include periprocedural myocardial ischemia over 24 hours measured by continuous ST-segment EKG monitoring and the composite clinical endpoint of death, nonfatal myocardial infarct, new or worsening heart failure, or recurrent ischemia at 30 days following the procedure. Full enrollment in the study is scheduled to be achieved before year-end.
In addition to treatment of angioplasty patients, preclinical research indicates the potential for MC-1 to reduce damage from other related ischemic conditions, such as heart attacks, coronary bypass surgery (CABG) and stroke. The ongoing MEND-1 trial will add support to Medicure's clinical and preclinical development efforts being directed at these other important medical needs.
"The initiation of patient enrollment in the MEND-1 trial, together with preclinical development work under way for related conditions such as stroke, demonstrates Medicure's commitment to the rapid advancement of MC-1 for these important unmet cardiovascular needs," stated Albert D. Friesen, Ph.D. President and CEO of Medicure. "We are pleased to have met this milestone and look forward to other clinical advancements through 2002."