MEND - CABG Study Preparing For Enrollment
WINNIPEG, Manitoba - November 20, 2003. Medicure
Inc. (TSX:MPH), a cardiovascular drug discovery and development
company, is pleased to announce that it has received approval from
the U.S. Food and Drug Administration (FDA) and the Canadian Therapeutic
Product Directorate (TPD) to initiate a large Phase II clinical
study to treat up to 900 patients with the Company's lead drug compound,
MC-1. The study, to be called MEND - CABG, will evaluate the ischemic
reperfusion and neuro-protective effects of MC-1 in patients undergoing
high-risk Coronary Artery Bypass Graft (CABG) surgery.
Coronary Artery Disease (CAD) is a condition in which the coronary
arteries become narrowed, thereby reducing the blood flow to the
heart muscle such that the heart does not get the nutrition and
oxygen it requires. 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.
While CABG surgery effectively relieves angina, and often results
in longer survival and a better quality of life, patients still
experience significant ischemic reperfusion injury during the procedure,
which can lead to subsequent problems such as myocardial infarction
(heart attack) or stroke. As such, there is a significant need for
a protective drug to reduce the extent of injury to the heart during
this procedure.
"FDA approval to commence this important study furthering
the clinical development of MC-1, represents a significant milestone
in the Company's history," stated Albert D. Friesen, PhD, Medicure's
President and Chief Executive Officer. "This will be a landmark
study for Medicure, and we are pleased and privileged to be working
with some of North America's leading cardiovascular surgeons and
interventionalists in numerous clinical centres in both Canada and
the United States. Having established MC-1's cardio protective capabilities
in angioplasty, we are excited at the prospect of showing its efficacy
in reducing ischemic reperfusion and neurological damage resulting
from the CABG procedure."
Dr. Jean-Claude Tardif, MD, FRCP, Director of Clinical Research
and Associate Professor of Medicine at Montréal Heart Institute
will chair the study's steering committee. Dr. Robert Harrington,
MD, Professor of Medicine and Director of Cardiovascular Clinical
Trials at Duke Clinical Research Institute and Dr. Robert Emery,
MD, President, Cardiac Surgical Associates in St. Paul, Minnesota,
will act as co-chairs.
The MEND-CABG trial will enroll patients undergoing elective CABG
surgery and will be conducted at 20 to 25 cardiac centres throughout
Canada and the US. The trial is a randomized, placebo-controlled,
double-blind, dose ranging study to evaluate the impact of MC-1
and determine its protective effect on combined cardiovascular and
neurological events after CABG surgery.
The primary efficacy endpoint of the trial will be the reduction
of the combined incidence of cardiovascular death, non-fatal myocardial
infarction (heart attack) and non-fatal cerebral infarction (stroke),
up to and including post-operative day 30. The secondary endpoints
will include, among others, the difference in CK-MB AUC (0 - 24
hours) as a marker of cardiovascular damage. This is the measure
in which MC-1's cardioprotective effect was first demonstrated in
the MEND-1 study with patients undergoing angioplasty procedure.
Drug safety will be assessed by an evaluation of types, frequencies,
severities and duration of any reported adverse experiences, and
by examination of clinical laboratory abnormalities. Patients will
be closely monitored for signs and symptoms of drug toxicity.
"Current therapies for patients undergoing CABG surgery fall
short in terms of effectiveness, and the necessity for a cardioprotective
drug for this growing health concern is indisputable," commented
Dr. Tardif. "Given earlier clinical results that demonstrated
MC-1's ability to significantly reduce the amount of damage to the
heart in patients undergoing angioplasty, I look forward to leading
this important new trial of this promising therapeutic intervention."
Patient Enrollment In MC - 4232 Hypertension Trial Progressing
Medicure also announced today that its Phase II trial of MC-4232,
the Company's second clinical candidate, was progressing well with
patient enrollment. The initial patients, all of whom are diabetics
with hypertension, have been enrolled in the first of a series of
exploratory trials. The trial will enroll 15 patients and is designed
to determine an effective dose-range for the treatment of hypertension
as a prelude to future Phase III studies.
"The data gathered from this trial will form the basis for
Medicure to move forward to a larger, pivotal Phase III clinical
trial of MC-4232 in 2004," said Robert G. Burford, PhD, Medicure's
Vice-President, Product Development. "We anticipate that preliminary
results will be available from this current study during the first
quarter of calendar 2004."
Hypertension is a common disorder in which blood pressure remains
abnormally high. Approximately 57 million adult North Americans
have high blood pressure. Of those, 73% of them are not adequately
controlled and have an increased risk of heart attack, stroke, kidney
failure, damage to the eyes, heart failure and atherosclerosis.
In addition, hypertension is two times more common in people with
diabetes than the rest of the population. Hypertension in the diabetic
patient is more difficult to control and normally requires treatment
with multiple medications. More than 17 million Americans have diagnosed
diabetes, of which approximately 3 million Americans also have hypertension.
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
