Category: Uncategorized
anuary 13, 2003

News Release: Positive Results From Phase II Trial On MC-1

Medicure Inc., a cardiovascular biotechnology company, today 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, PhD, 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, MD, F.A.C.C., 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. MD, F.A.C.C., Associate Professor of Medicine, Duke University Medical Center. Dr. Tcheng is an internationally regarded leader in interventional cardiology and clinical trials.

'The need to find agents that can reduce or eliminate myocardial injury during PCI, coronary artery bypass surgery or as a consequence of acute myocardial infarction is immense,'stated Dr. Tcheng. 'These results strongly support Medicure moving forward to evaluate MC-1 in pivotal, large scale clinical trials.'

Regarding the results, Dr. Paul Armstrong, MD, Chair of Medicure's Scientific Advisory Board and Professor of Cardiology, Department of Medicine, University of Alberta said: 'This clinical trial has provided an important positive signal for Medicure's lead compound and demonstrated its ability to identify and develop important drugs in the cardiovascular field. It is a clear indication that Medicure has a promising drug candidate that has potential application in a variety of unmet areas amongst common coronary heart problems. I look forward to helping move this and other initiatives forward.'

The full results from the Phase II clinical study will be presented by Dr. Tcheng in connection with the Annual Meeting of the American College of Cardiology in Chicago, March 30-April 2, 2003.

The success achieved through this clinical trial represents a major high point for Medicure, noted Dr. Friesen: 'We are optimistic that these results will be positively viewed by prospective partners.'

Dr. Friesen also stated that the success of the Phase II trial is a 'reflection of the expertise, commitment and dedication of Dr. Harrington and his team of scientists at the DCRI, and the Medicure staff.'

Medicure's research and development investment into MC-1's cardioprotective effect was initiated by Company co-founder, Dr. Naranjan Dhalla, PhD., Director, Institute of Cardiovascular Sciences, a world-renowned cardiovascular researcher.

Notification of Conference Call

Date: TUESDAY, JANUARY 14, 2003

Time: 3:00 P.M., EASTERN STANDARD TIME

Telephone Access: 1-877-461-2816 OR, 416-695-5261

About Medicure Inc.

Medicure Inc. is a cardiovascular drug discovery and development Company focused on developing effective therapeutics for unmet needs in the field of cardiovascular medicine including the prevention and treatment of ischemia, ischemic reperfusion injury, and stroke.

This press release contains forward-looking statements that involve risks, which may cause actual results to differ materially from the statements made, and accordingly may be deemed to be forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements are made as of the date hereof, and the Company disclaims any intention and has no obligation or responsibility to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

CONTACT: TEL: (888) 435-2220 Don Bain, Director, Investor Relations,
FAX: 1-204-488-9823 Medicure Inc.
E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
Internet: www.medicureinc.com

WEBSITE This email address is being protected from spambots. You need JavaScript enabled to view it.

Videos / Webinars

View all videos