MEDICURE GETS FDA/TPD APPROVALS FOR MC-1 PHASE II TRIAL.
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 CEO. "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 Montreal 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 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.
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.
For more information, call 888/435-2220 or visit http://mwww.medicureinc.com.
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|Date:||Jan 1, 2004|
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