MEDICURE GETS FDA/TPD APPROVALS FOR MC-1 PHASE II TRIAL.Medicure Inc. (TSX TSX Toronto Stock Exchange (TSE before April, 2002)
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TSX True Space Extension :MPH), Winnipeg, Manitoba, a cardiovascular drug discovery and development company, has received approval from the U.S. Food and Drug Administration and the Canadian Therapeutic Product Directorate (TPD TPD Tons Per Day
TPD Therapeutic Products Directorate
TPD Total and Permanent Disablement (insurance)
TPD Temperature Programmed Desorption
TPD Temporary Partial Disability (insurance) ) 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 CABG coronary artery bypass graft.
coronary artery bypass graft
CABG Coronary artery bypass graft, see there , will evaluate the ischemic reperfusion ischemic reperfusion,
n the restoration of blood flow to an area that had previously experienced deficient blood flow. Oxidative stresses associated with this situation may cause damage to the affected tissues or organs. and neuro- protective effects of MC-1 in patients undergoing high-risk Coronary Artery Bypass Graft coronary artery bypass graft
n. Abbr. CABG
A surgical procedure in which a section of vein or other conduit is grafted between the aorta and a coronary artery below the region of an obstruction in that artery. (CABG) surgery.
Coronary Artery Disease coronary artery disease, condition that results when the coronary arteries are narrowed or occluded, most commonly by atherosclerotic deposits of fibrous and fatty tissue. (CAD) is a condition in which the coronary arteries Coronary arteries
The two main arteries that provide blood to the heart. The coronary arteries surround the heart like a crown, coming out of the aorta, arching down over the top of the heart, and dividing into two branches. 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.
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "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 The United States and Canada share a unique legal relationship. U.S. law looks northward with a mixture of optimism and cooperation, viewing Canada as an integral part of U.S. economic and environmental policy. . 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 FRCP Fellow of the Royal College of Physicians.
Fellow of the Royal College of Physicians , director of clinical research and associate professor of medicine at Montreal Heart Institute The Montreal Heart Institute (French: Institut de Cardiologie de Montréal), in Montreal, Quebec, is a specialty hospital dedicated to the development of cardiology. Founded in 1954, it is currently affiliated with the Université de Montréal. 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 ran·dom·ize
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment. , 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 CK-MB Creatine phosphokinase MB isoenzyme Cardiology A CK isoenzyme usually ↑ in acute MI; CK-MB may be ↑ in muscular dystrophy, polymyositis, myoglobinuria, malignancy–eg, lung CA. Cf Troponin I, Troponin T. AUC AUC
area under curve (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 Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the 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.