MPH-T NR today 79m at 1.95
Medicure gets positive results in MEND-CABG phase II
2006-04-06 09:21 ET - News Release
Mr. Derek Reimer reports
MEDICURE REPORTS POSITIVE POD 90 RESULTS FROM THE MEND-CABG STUDY -- MC-1 TREATMENT EFFECT MAINTAINED AT 90 DAYS POST OPERATIVELY
Medicure Inc. has received positive postoperative day (POD) 90 results with its lead cardioprotective product, MC-1, from the phase II MEND-CABG study. The MEND-CABG study was a double-blind, parallel-group, randomized, placebo-controlled study in 902 patients who underwent coronary artery bypass graft (CABG) surgery.
The primary end point of MEND-CABG was the reduction in the composite of cardiovascular death, non-fatal myocardial infarction (heart attack), and non-fatal stroke up to POD 30. Positive POD 30 results were reported in Stockwatch on Dec. 5, 2005. In addition to the POD 30 analysis, the study protocol included following study patients for 90 days postoperatively (POD 90) for further safety and efficacy analysis.
MEND-CABG study results
The MEND-CABG POD 90 results further demonstrated the positive clinical effects of MC-1:
the clinical results reported at POD 30 with MC-1, as noted below, were maintained throughout the follow-up period; and
the safety analysis demonstrated MC-1 was safe and well tolerated. The incidence of adverse events in the study was comparable across both treatment and control groups.
The MEND-CABG POD 30 results released in December, 2005, demonstrated the positive clinical effects of MC-1:
the 250-milligram dose of MC-1 had a 37.2-per-cent reduction in the composite of cardiovascular death, non-fatal myocardial infarction (peak CK-MB greater than or equal to 100 ng per millilitre), and non-fatal stroke compared with placebo (p equals 0.028);
the reduction in the composite end point was driven by a substantial decrease in the incidence of non-fatal myocardial infarction, most notably a 46.9-per-cent reduction in non-fatal myocardial infarction (peak CK-MB greater than or equal to 100 ng per millilitre) with the 250 milligrams of MC-1 compared with placebo (p equals 0.008); and
the 250-milligram dose of MC-1 had a 14-per-cent reduction in the primary end point composite of cardiovascular death, non-fatal myocardial infarction (peak CK-MB greater than or equal to 50 ng per millilitre), and non-fatal stroke compared with placebo (p equals 0.312).
Medicure plans to present the detailed results from MEND-CABG, including the POD 90 analysis, at an upcoming scientific conference.
"The maintenance of the clinical reductions at POD 90 further supports MC-1's ability to significantly reduce heart attacks in this high-risk patient population and clearly warrant advancing MC-1 into pivotal phase III development," commented Medicure's president and chief executive officer, Dr. Albert Friesen, PhD. "These results suggest that MC-1 could represent a major therapeutic breakthrough in the treatment of acute ischemia and ischemic reperfusion injury. We will meet with the FDA to discuss these results and develop the phase III program, which we anticipate commencing in the second half of 2006."
MEND-CABG study
The MEND-CABG trial was designed to evaluate the cardioprotective and neuroprotective effects of MC-1 in high-risk coronary artery disease patients undergoing CABG surgery. The trial enrolled 902 patients at 42 investigational sites throughout Canada and the United States. The study was a double-blind, parallel-group, randomized, placebo-controlled study in patients who underwent coronary artery bypass graft surgery. Study patients received placebo or MC-1 (250 milligrams or 750 milligrams) on the day of surgery and for 30 days postoperatively (POD 30). The primary end point of MEND-CABG was a reduction in the composite of cardiovascular death, non-fatal myocardial infarction (heart attacks), and non-fatal stroke up to POD 30. Study patients were followed for 60 days after treatment (90 days postoperatively) for additional safety and efficacy analysis.
MC-1
MC-1 is a naturally occurring small molecule that reduces the amount of damage to the heart following ischemia or ischemic reperfusion injury. Studies with MC-1 suggest that it does this by protecting cardiomyocytes (heart muscle cells). Since cardiomyocytes are essential for normal heart function and do not regenerate themselves following an ischemic event, their preservation is key to minimizing ischemic damage and maintaining proper heart function. MC-1's cardioprotective properties have now been demonstrated in the phase II MEND-1 study in patients undergoing percutaneous coronary interventions and the phase II MEND-CABG study in patients undergoing CABG surgery.
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