Medicure Inc announced positive results with treatment from its lead compound MC-1 in the recently completed Phase II MEND-1 clinical study managed by the Duke Clinical Research Institute (DCRI) in Durham, North Carolina.
Both the primary and secondary endpoints of the Phase II MEND-1 study were met. The primary endpoint of the trial was infarct size (area of the heart that is damaged) during the procedure as determined by the release of the amount of the marker cardiac enzyme, CK-MB, over 24 hours following percutaneous coronary intervention (PCI). Improvement was also shown in certain secondary endpoints, including myocardial ischemia measured by continuous ST-segment electrocardiographic monitoring, peak periprocedural CK-MB through 24 hours and clinical tolerability and safety.
The Phase II trial was an investigation of the cardioprotective effects of MC-1 in mitigating damage caused by ischemia and ischemic reperfusion in heart disease patients undergoing angioplasty.
"The results from this clinical trial met and exceeded our expectations," stated Albert D. Friesen, Medicure President and CEO. "They showed that MC-1 reduces ischemic heart damage following angioplasty and demonstrated MC-1's potential to be an effective drug for the treatment of ischemia and ischemic reperfusion injury. MC-1 is a new class of drug and the Phase II results provide a solid base for further clinical trials in this and other cardiovascular conditions."
MEND -1 was a randomized, placebo-controlled, blinded study, which evaluated the extent of damage to the heart muscle following elective PCI in 60 high risk patients at increased risk for cardiac damage. Damage to the heart was assessed by quantifying the release of the cardiac enzyme CK-MB, commonly used to diagnose myocardial infarct (heart attack). Treatment with MC-1 reduced the release of CK-MB following PCI.
"MC-1 represents a significant opportunity to improve the lives of many individuals suffering from cardiovascular disease," stated Dr. Friesen. "These results support our belief that MC-1 could provide hope for many victims of such debilitating and inadequately treated interventions and conditions as angioplasty, coronary artery bypass graft and acute myocardial infarction. This trial also showed that MC-1 was safe in heart patients when taken in conjunction with other drugs."
Ischemia and ischemic reperfusion affect millions of people in the Western World. It is estimated that more than 1 million angioplasty procedures are performed each year in North America. In addition, approximately 7.3 million North Americans suffer an Acute Myocardial Infarction annually, while another 6.2 million suffer from angina. Cardiovascular disorders continue to be the number one cause of death in the Western world. More than 60 million North Americans are affected by some form of cardiovascular disease or stroke.
The MEND-1 clinical study was managed by the Duke Clinical Research Institute (DCRI) in Durham, North Carolina, a recognized leader in cardiovascular clinical trials, clinical drug research and the evaluation of novel therapeutics. Dr. Robert A. Harrington, is the Director of Cardiovascular Clinical Trials at DCRI, and he oversaw the MEND-1 clinical study. Dr. Harrington also is an Associate Professor of Medicine at Duke University Medical Center.
MEND-1 was conducted at four cardiac centers in Canada and the United States under the direction of Principal Investigator, Dr. James E. Tcheng, Associate Professor of Medicine, Duke University Medical Center. Dr. Tcheng is an internationally regarded leader in interventional cardiology and clinical trials.