Vericel shares jump after heart trial success

Shares in US biotech Vericel have doubled in price after top line results showed its ixmyelocel-T met primary endpoint in a phase 2b trial, in advanced heart failure due to ischaemic dilated cardiomyopathy.

Following the announcement late on Thursday, shares on the NASDAQ exchange jumped to more than $4 from a base of just over $2.

The trial met its primary endpoint of reduction in total number of deaths, cardiovascular hospitalisations, 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.

Incidence of adverse events, including serious adverse events, in patients in the ixmyelocel-T group was comparable with a placebo group.

The ixCELL-DCM clinical trial is a multicentre, randomised, double-blind, placebo-controlled phase 2b study designed to assess the efficacy, safety and tolerability of ixmyelocel-T compared to placebo when administered via transendocardial catheter-based injections to subjects with end-stage heart failure due to ischaemic DCM, who have no revascularisation options, either surgical or percutaneous interventional.

The trial was designed to provide approximately 80% power to show a 46% difference in cardiac events for ischaemic DCM patients treated with ixmyelocel-T compared to placebo. A total of 114 patients were treated in the ixCELL-DCM clinical trial at 28 sites in the US.

The full data results from the ixCELL-DCM trial are scheduled to be presented at the upcoming American College of Cardiology 65th Annual Scientific Session next month, and also will be submitted for publication.

Ixmyelocel-T is a multicellular therapy manufactured from a patient's own bone marrow using Vericel's cell processing system.