Vericel Corp (NASDAQ:VCEL), better known for developing patient-specific cellular therapies, announced top-line results of ixmyelocel-T’s Phase 2b ixCELL-DCM clinical trial. This trial focuses on those patients who suffer from advanced heart failures due to critical health problem called ischemic dilated cardiomyopathy.
Insights of The Matter
The primary endpoint of this trial was to demonstrate a reduction in the overall deaths, emergency department visits and unplanned outpatient. Thanks to the dedication shown by the entire team responsible for the development that it met its initial endpoint without any hassle. Vericel had formed an independent adjudication committee to adjudicate all the clinical events in its primary and secondary endpoints. The incidence of adverse events in those patients who were treated with ixmyelocel-T could easily be compared with other patients belonging to the placebo group.
As a reward for company’s hard work and dedication, U.S. Food and Drug Administration has granted orphan product designation to Ixmyelocel-T for being used in DCM treatment. DCM or Dilated cardiomyopathy is a heart disease and lead to a number of heart failure incidents around the world.
The successful outcome in the Phase 2b clinical trial of ixCELL-DCM is the result of the collective effort made by the production team as well as the senior management employees during the study period.
Vericel considered over 114 patients from 28 sites to be treated in the ixCELL-DCM clinical trial. It will announce full data results of this trial at the Late-Breaking Clinical Trial Sessions, scheduled to take place during the 65th Annual Scientific Session & Expo at the American College of Cardiology on April 4, 2016.
In an official statement, Vericel announced that its long-awaited experimental heart drug was able to reduce hospitalizations, deaths and emergency visits. It will continue to make attempts towards improving these results in the coming months.
As soon as this update hit the market, Vericel’s shares surged 24% in pre-market trading.