Medicure Inc., a cardiovascular focused biopharmaceutical company, has announced that Duke Clinical Research Institute (DCRI) and Montreal Heart Institute (MHI) have agreed to lead the upcoming phase III Coronary Artery Bypass Graft (CABG) study with MC-1. The study, titled MEND-CABG II, will enrol up to 3000 patients at over 120 sites throughout North America and Europe.
The principal investigators for MEND-CABG II will be Dr Robert Harrington, Prof. of Medicine, and Director of Cardiovascular Clinical Trials at DCRI and Dr Michel Carrier, Director of cardiovascular surgery programme at MHI. Dr. Jean-Claude Tardif, Director of the Research centre, MHI, will serve as co chair of the MEND-CABG II steering committee together with Dr Robert W. Emery, Jr, Cardiac Surgical Associates.
"We are happy to continue our relationship with DCRI and MHI for the MEND-CABG II study," commented Medicure's President and CEO, Albert D Friesen, PhD. "Drs Harrington, Carrier, Emery and Tardif are recognized worldwide for their leadership and expertise in cardiovascular clinical research, and we have leveraged their knowledge and experience in the design of MEND-CABG II."
"I am pleased to carry on the long standing relationship between Medicure and DCRI that has included the management of their two previous phase II studies with MC-1, MEND-1 and MEND-CABG," stated Dr Robert Harrington. "The mechanism of action of MC-1, protecting the heart at the cellular level, is a novel approach to managing ischemic reperfusion injury, and it has shown positive results in two phase II studies. The cardiovascular community will be intently watching the outcome of this phase III study, as its result, if positive, could have a significant benefit and lasting impact on how CABG patients are treated."
"As a cardiothoracic surgeon I am intimately aware of the risks surrounding CABG surgery, and the need for cardio protection in this area," commented Dr Carrier. "There have been significant advancements in surgical techniques and antithrombotic therapy to improve CABG outcomes, yet the approval of a drug to protect the heart by mitigating the effects of ischemic reperfusion has evaded us. As a result the unmet medical need MC-1 would meet is considerable."
"I look forward to working with Medicure on this pivotal study, and continuing the relationship that began with Montreal Heart's management of the MEND-CABG study", stated Dr Jean-Claude Tardif. Both Dr Tardif and Dr Emery were involved in the Phase II MEND-CABG study, Dr. Tardif as the principal investigator, and Dr Emery as a member of the steering committee.