Trial to Evaluate MC-1 in Patients Undergoing
Coronary Artery Bypass Surgery
WINNIPEG, Manitoba - (April 5, 2004) - Medicure
Inc. (TSX: MPH / Amex: MCU), a cardiovascular drug discovery and
development company, is pleased to announce that the first patients
have been enrolled in the Company's Phase II/III MEND-CABG clinical
trial. The study will evaluate the cardioprotective and neuroprotective
effects of MC-1 in patients undergoing high-risk Coronary Artery
Bypass Graft (CABG) surgery.
The MEND-CABG study is a placebo controlled, double-blinded study
of MC-1, designed to evaluate the potential of Medicure's lead drug
in reducing ischemic damage resulting from CABG procedures. The
study's primary efficacy parameter is the reduction in combined
incidence of cardiovascular and cerebrovascular death, non-fatal
myocardial infarction (heart attack) and non-fatal cerebral infarction
(stroke), up to and including 30 days following CABG surgery. To
assess the objective, the incidence in each of two dose groups -
250 mg and 750 mg per day - will be compared to the incidence in
the placebo group. Secondary efficacy endpoints include evaluating
the effect of MC-1 at 90 days following surgery on the same composite
of events, measures of cardiac tissue damage as determined by CKMB
and neurological function.
Safety will be assessed by clinical laboratory parameters, electrocardiograms,
physical examinations, vital signs, and the frequency and intensity
of clinical adverse events. In addition, patients will be closely
monitored for signs and symptoms of drug toxicity.
The first patients were enrolled at the Montreal Heart Institute
(MHI), which, along with Duke Clinical Research Institute (DCRI)
will manage the trial. The Phase II component of the Phase II/III
trial will enroll up to 900 patients - 300 per arm - at approximately
40 investigational sites located throughout Canada and the United
States. Enrollment is expected to take up to 12 months to complete.
"The start of the CABG study signifies a major step toward
the registration of MC-1 by the FDA," stated Albert D. Friesen,
PhD, Medicure's President and Chief Executive Officer. "This
trial is a key component of our strategy to establish MC-1 as a
cardioprotective and neuroprotective treatment for events involving
ischemia and ischemic reperfusion injury.
"Data from our MEND-1 Phase II trial last year provided significantly
positive results in reducing ischemic damage in patients undergoing
angioplasty procedure, and we are excited about this next important
stage in the clinical development of MC-1," added Dr. Friesen.
Jean-Claude Tardif, MD, FRCP, Associate Professor of Medicine at
Montreal Heart Institute and Director, MHI Research Centre, is the
trial's Principal Investigator and Chairman of the Steering Committee.
Commenting on the MEND-CABG trial, Dr. Tardif stated: "In patients
with obstructive coronary artery disease, coronary artery bypass
graft surgery is an effective procedure for relieving angina, increasing
survival and improving the quality of life for the majority of patients.
However, the procedure does carry a risk of serious adverse outcomes
resulting from ischemia and reperfusion injury to cardiac and brain
tissue. There is therefore a need for a pharmacological intervention
that would provide further cardiovascular protection in patients
undergoing CABG surgery.
"The MEND-1 trial demonstrated that MC-1 decreases the myocardial
damage associated with percutaneous coronary intervention (PCI)
procedures. As such, it now becomes important to evaluate the impact
of longer-term treatment with MC-1 in the prevention of the adverse
cardiovascular and neurovascular consequences of CABG surgery. The
MEND-CABG trial represents an opportunity to evaluate this promising
compound for cardiovascular and neurological protection in a significant
patient population," he added.
CABG is a medical procedure performed to improve blood flow to
the heart by re-routing blood around the blocked artery. Due to
the high incidence of coronary artery disease worldwide, as well
as the effectiveness of this surgical procedure, CABG surgery is
one of the top 10 most frequently performed procedures in North
America. It is estimated approximately 700,000 CABG procedures are
performed every year in the United States.
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. The Company's lead drug,
MC-1, is focused on the prevention and treatment of ischemia, ischemic
reperfusion injury, and stroke. The cardiovascular and stroke market
is the largest pharmaceutical sector with annual global sales of
over US $70 billion.
The Company's second product candidate, MC-4232, is being targeted
for the treatment of hypertension, a common disorder in which blood
pressure remains abnormally high. Approximately 73% of the more
than 50 million adult Americans who have hypertension, are not adequately
treated.
Medicure also has a medicinal chemistry based Drug Discovery program
focused on discovery and advancement of novel small molecule, anti-ischemics
and anti-thrombotics towards human clinical studies.
This news 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:
Derek Reimer
Chief Financial Officer
Don Bain
Director of Investor & Public Relations
