Montréal Heart Institute, Duke Clinical Research Institute to Collaborate on Trial
WINNIPEG, Manitoba - (October 15, 2003).
Medicure Inc. (TSX:MPH), a cardiovascular drug discovery and development
company, is pleased to announce that it has filed for regulatory
approval with the U.S. Food and Drug Administration (FDA) and Canada's
Therapeutics Product Directorate (TPD) to conduct a Phase II clinical
study of the Company's lead drug candidate, MC-1, to evaluate the
cardioprotective and neuroprotective effects of the drug in patients
undergoing high-risk Coronary Artery Bypass Graft surgery (CABG).
The objective of the trial is to assess the effects of MC-1 compared
with placebo on cardiovascular events and neurological functions
following CABG surgery and to determine the level of protection
against ischemia reperfusion injuries during cardiac surgery.
Montréal Heart Institute, in collaboration with Duke Clinical
Research Institute (DCRI), Durham, North Carolina, will undertake
the North American, multi-centre, double-blind study at between
20 and 30 clinical sites. Up to 900 patients undergoing the CABG
procedure will be enrolled in the dose response study, which will
be carried out under the direction of Dr. Jean-Claude Tardif, MD,
FRCP, Director of Clinical Research and Associate Professor of Medicine
at the Montreal Heart Institute, and Dr. Robert Harrington, Professor
of Medicine and Director of Cardiovascular Clinical Trials, Duke
University Medical Centre.
"As is the case with all surgeries, there are risks involved.
In the case of CABG, the procedure is associated with several complications
involving the cardiovascular and central nervous system," stated
Dr. Tardif. "As such, there is a significant need for a protective
drug to reduce the extent of injury to the heart during this procedure.
We are very much looking forward to carrying out this multi-centre
trial in conjunction Duke Clinical Research Institute in patients
undergoing this procedure."
In Medicure's MEND-1, Phase II clinical trial, MC-1 showed that
it did have a cardioprotective effect on ischemic reperfusion injury
in patients undergoing angioplasty procedure.
The primary efficacy parameter of the trial is reduction in the
combined incidence of cardiovascular and cerebrovascular death,
non-fatal myocardial infarction (heart attack) and non-fatal cerebral
infarction (stroke), up to and including post-operative day 30.
Additional endpoints will include the extent of CK-MB released as
a marker of cardiovascular damage, the measure in which MC-1's cardioprotective
effect was first demonstrated in the MEND-1 study. Safety will be
assessed by clinical laboratory parameters, electrocardiograms,
physical examinations, vital signs, and the frequency and intensity
of clinical adverse events.
In addition to Drs. Tardif and Harrington, the Steering Committee
that will drive the CABG trial is comprised of several leading physicians
in the field of cardiology: Dr. Michel Carrier, Department of Surgery,
Montréal Heart Institute; Dr. David Kandzari, Assistant Professor
of Medicine and Director, Interventional Cardiology Research at
Duke Clinical Research Institute; Dr. Robert Emery, President, Cardiac
Surgical Associates, St. Paul, Minnesota; Dr. Robert Côté,
Associate Professor/Physician, Division of Neurology and Clinical
Epidemiology, Montreal General Hospital; and Dr. Therese Heinonen,
Montréal Heart Institute. Representing Medicure on the committee
are: Karl-Gunnar Hidinger, PhD, Vice-President, Clinical Development,
and Dr. Ahmad Khalil, Director of Scientific Affairs.
"We are honoured to have some of North America's leading cardiovascular
surgeons and interventionalists participate in this trial,"
said Albert D. Friesen, PhD, Medicure's President & Chief Executive
Officer. "This further solidifies our belief in MC-1 and their
involvement will be of great value to the Company as we move forward
in the development of MC-1 as a leading cardioprotective drug."
In addition, Dr. Hidinger, noted that the Company was pleased with
the of development of MC-1 thus far: "Moving to CABG is a logical
extension of MC-1, which previously demonstrated benefit in reducing
damage associated with angioplasty. This represents an important
part of Medicure's objective of establishing the drug as a cardioprotective
treatment for a variety of situations involving ischemic and reperfusion
injury. Given the steady progress that has been made thus far, we
remain committed to moving forward with our clinical development
program and staying on track with regard to established timelines."
About Montréal Heart Institute
The Montréal Heart Institute is a world-renowned and highly
specialized university hospital and cardiology centre, which promotes
cardiology research, develops new technologies and contributes to
the prevention of cardiovascular disease by providing rehabilitation
conditions that best meet patients' needs. Over 100 scientists -
more than 60 experienced researchers and 50 fellows - work at the
Research Centre. In all, the Research Centre has a staff of over
500.
About Duke Clinical Research Institute
Duke Clinical Research Institute is a world leader in cardiology
clinical trials and clinical drug research. It combines the clinical
expertise and academic leadership of a premier teaching hospital
with the full-service operational capabilities of a major contract
research organization. With nearly 900 faculty and staff, DCRI combines
the scientific thought leadership of Duke University Medical Centre
with significant outstanding clinical trials operational capabilities
to perform Phase II to IV trials and outcomes.
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
