WINNIPEG, MANITOBA (January 14, 2003) - Medicure Inc. (TSX:
MPH), 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.
For more information, please contact:
Don Bain
Director, Investor Relations
Medicure Inc.
Tel. 888-435-2220
Fax 204-488-9823
dbain@medicure.com
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