FDA Puts Medicure’s Ischemia Drug on the Fast Track
May 18, 2007 — Medicure, a biopharmaceutical company focused on the research, development and commercialization of novel compounds to treat cardiovascular disorders, is developing MC-1 for the treatment of acute ischemia and ischemic reperfusion injury, and has received a Fast Track Designation from the FDA for the drug.
Currently, MC-1 has completed two positive Phase 2 studies, one in angioplasty patients and most recently a 901-patient coronary artery bypass graft (CABG) study, called MEND-CABG.
In the MEND-CABG study, patients undergoing coronary artery bypass graft surgery who received biopharmaceutical company Medicure’s lead drug MC-1 in Phase II clinical trails showed a 47 percent decrease in postoperative hearts attacks. MC-1 is currently being evaluated in a Phase 3 trial (MEND-CABG II) that is enrolling up to 3,000 patients undergoing CABG surgery at approximately 120 cardiac surgical centers throughout North America and Europe . Medicure is conducting the Phase 3 study in conjunction with the Duke Clinical Institute (DCRI) and Montreal Heart Institute (MHI). If successful, the trial could lead to approval of MC-1 for sale in the U.S.
"Some doctors have been less inclined to recommend bypass surgery for their patients because of the risk associated with the procedure, including postoperative heart attacks,” stated Dr. Robert Harrington of Duke Clinical Research Institute. “Unfortunately there are currently no approved drugs to specifically lessen that risk."
For more information visit www.medicure.com.