Vericel Corp. announced on March 10 that its experimental drug to treat advanced heart failure due to ischemic dilated cardiomyopathy met the primary endpoint in a phase 2b clinical trial.
After a year of treatment, patients with end-stage heart failure due to ischemic dilated cardiomyopathy acute decompensated heart failure who received ixmyelocel-T had reductions in the total number of deaths, cardiovascular hospitalizations or unplanned outpatient and emergency department visits compared with those who received placebo.
The incidence of adverse events and serious adverse events were similar between the ixmyelocel-T and placebo groups.
In December, the FDA granted ixmyelocel-T an orphan drug designation to treat decompensated heart failure. The medication is administered via transendocardial catheter-based injections and is intended for patients who will not likely benefit from surgical or percutaneous interventional revascularization options.
Vericel Corp. said it would present full results of the multicenter, randomized, double-blind, placebo-controlled trial during a late-breaking clinical trial session at the American College of Cardiology’s Scientific Session on April 4 in Chicago.
The trial enrolled 114 patients who were treated at 28 sites in the U.S.