WINNIPEG, MANITOBA (March 31, 2003) - Last night, at a satellite symposium of the 52nd
Annual Scientific Sessions of the American College of Cardiology
in Chicago, Illinois, Medicure Inc.
(TSX: MPH), a cardiovascular biotechnology company and Duke Clinical
Research Institute, announced the results of the recently completed
phase II MEND-1 clinical study of Medicure's
lead drug, MC-1.
The results
were presented by Dr. James E. Tcheng, MD, F.A.C.C., Associate Professor
of Medicine, Duke University Medical Center and the Principal Investigator
of the trial. He was joined by Dr. Robert A. Harrington, MD, Professor
of Medicine, Duke University Medical Centre, Dr. Paul W. Armstrong,
MD, Professor of Cardiology, Department of Medicine, University
of Alberta and Chair of the Medicure
Scientific Advisory Board, and Dr. Albert D. Friesen, PhD., Chairman,
President and CEO of Medicure.
The MEND-1 trial
(MC-1 to Eliminate Necrotic
Damage) was a proof of principle study to establish the efficacy
and safety of Medicure's lead
compound, MC-1 as a cardioprotective
treatment to reduce damage to the heart associated with acute ischemic
and reperfusion injury. The trial enrolled a total of 60 high-risk
patients undergoing percutaneous coronary intervention (PCI), and
was conducted at four medical centres in Canada and the USA. Patients
were randomized to receive either MC-1
(n=40) or placebo (n=20).
The primary
endpoint, peri-procedural infarct size (as determined by area under
the curve (AUC) of CK-MB within 24 hours following initiation of
elective PCI) was significantly reduced by approximately 33% in
the MC-1 treatment group. Compared
with the placebo group, the peak absolute CK-MB in the MC-1
patients was also reduced by 30% relative to the placebo group.
With respect
to secondary endpoints, there were no significant statistical differences
between the MC-1 treatment group
and the placebo group in the composite clinical endpoint of death,
nonfatal MI, new or worsening heart failure, or recurrent ischemia
at 30 days, or in any of the individual components of the composite
endpoint. These efficacy results were achieved without any significant
adverse effect on hemorrhaging, stroke, death or hepatic dysfunction,
thus confirming the safety and tolerability of the drug candidate.
Treatment for the study was in the presence of standard medical
care.
"As we
stated in January, the overall results from this clinical study
far exceeded our expectations in providing statistically significant
evidence of MC-1's ability to
reduce heart damage following angioplasty," said Dr. Friesen.
"Based on these results, Medicure is proceeding with the further
development of MC-1 through
additional trials to be initiated later this year. We anticipate
the product to display significant advantages over existing therapies
with respect to improved efficacy."
Commenting on
the results, Dr. Tcheng said: "Millions of heart-related procedures
are being performed every year, including PCI and bypass surgery,
where myocardium is at risk. There is an urgent medical need to
find new therapeutics that limit or prevent reperfusion damage and
the ischemia-mediated necrosis associated with these procedures.
These results support the further evaluation of MC-1
in pivotal trials of patients at risk for developing myocardial
ischemia, infarction or reperfusion injury."
Dr. Armstrong,
said: "The effect seen in the small patient population in a
condition where the size of the signal being measured (i.e. elevation
of CK-MB) was relatively small, provides enthusiasm to proceed with
MC-1 in clinical studies for
Coronary Artery Bypass Graft (CABG) and Acute Myocardial Infarction
(heart attack) where the amount of damage, and therefore the opportunity
to show improvement, is substantially greater.
"Similarly,
the demonstration of clinical safety in a high-risk cardiovascular
population receiving various other treatments is reassuring and
also supports further clinical evaluation. The safety of this naturally
occurring compound is a welcome feature that will enhance clinical
acceptance of this novel approach," he added.
The study was
conducted under approvals of both the FDA in the United States and
the TPD (Therapeutic Products Directorate) in Canada. Central management
was provided by Duke Clinical Research Institute, Durham, NC (DCRI),
an international leader in cardiovascular clinical evaluation. Patients
were enrolled at four sites in Canada and USA including: St. Michaels
Hospital, Toronto; Sunnybrook Hospital, Toronto; Ottawa Heart Institute,
Ottawa; and, Duke University Medical Center, Durham, NC.
Cardiovascular
disorders are the leading causes of death in the Western world.
More than 60 million Americans alone are affected by some form of
cardiovascular disease or stroke.
Notification
of Conference Call to Discuss The Results from MEND-1:
Date: Tuesday, April 1, 2003
Time: 11 a.m. Eastern Time
Dial-in Numbers: 1-877-667-7774; 416-695-6120
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 of Investor & Public Relations
Medicure Inc.
Tel. 888-435-2220/Fax 204-488-9823
info@medicure.com
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