Vericel stock nearly doubles as heart failure drug meets primary endpoint in mid-stage trial
pharmafile | March 11, 2016 | News story | Medical Communications, Research and Development |Â Â Â
Shares in US-based biotech firm Vericel nearly doubled on the Nasdaq on Thursday as the company reported its heart failure drug met the primary end-point in mid-stage trials.
The maker of cell therapy products announced top-line results for its trial-drug ixmyelocel-T showed a reduction in the total number of deaths, cardiovascular hospitalizations or unplanned outpatient and emergency department visits to treat acute decompensated heart failure during the 12 months following treatment with ixmyelocel-T compared to placebo.
Dr David Recker, Vericel’s chief medical officer, said: “The results of the ixCELL-DCM study, which we believe is the largest randomized cell therapy trial to treat congestive heart failure completed to date, demonstrated a statistically significant and clinically meaningful reduction in cardiac events in patients who received treatment with ixmyelocel-T compared to placebo. We are very excited about these study results given the lack of treatment options for end-stage heart failure patients.”
In the ixCELL-DCM trial, 114 patients with end-stage heart failure due to ischemic dilated cardiomyopathy who have no reasonable revascularisation likely to provide clinical benefit were randomised to treatment with ixmyelocel-T or placebo administered via transendocardial catheter-based injections, the company said in a statement.
Vericel said the therapy was granted orphan drug status to treat dilated cardiomyopathy by the US Food and Drug Administration (FDA).
Shares in the company closed up $1.83 at $3.95 on the Nasdaq on Thursday.
Anjali Shukla
