Vericel (VCEL) Announces Presentation of Data from ixCELL-DCM Trial at AHA

November 14, 2016 2:02 PM EST

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Vericel Corporation (NASDAQ: VCEL), a leading developer of autologous expanded cellular therapies for the treatment of severe diseases and conditions, today announced the presentation of additional pre‑specified secondary endpoint results from the ixCELL-DCM trial at the American Heart Association (AHA) Annual Meeting Scientific Sessions. As previously presented in a late-breaking clinical trial session at the American College of Cardiology’s (ACC) 65th Annual Scientific Session, the ixCELL-DCM trial met its primary endpoint with a 37% reduction in the composite endpoint, primarily driven by a reduction in all cause deaths and cardiovascular hospitalizations in patients with advanced heart failure due to ischemic dilated cardiomyopathy (DCM). As previously reported, the composite endpoint was all-cause deaths, cardiovascular hospitalizations, or unplanned outpatient and emergency department visits to treat acute decompensated heart failure. The overall incidence of adverse events, including serious adverse events, was comparable or lower in the ixmyelocel-T than in the placebo group.

In a poster session today at the AHA Scientific Sessions (Abstract 19491), Dr. Tim Henry, director of cardiology at Cedars‑Sinai Heart Institute, presented supportive secondary endpoint data for the ixCELL‑DCM study, a Phase 2b, randomized, double‑blind, placebo‑controlled study in 114 treated patients with advanced heart failure. A pre-specified secondary endpoint included the measurement of ventricular arrhythmia episodes resulting in appropriate shocks or ATP (anti-tachycardia pacing). Ventricular arrhythmias, a form of abnormal heart rhythm that originates in the ventricles of the heart, are associated with sudden death and are common in patients with heart failure and cardiomyopathy (Koplan 2009) At 12 months follow‑up, patients who received ixmyelocel‑T had a 24% reduction in ventricular arrhythmia episodes compared with the placebo group [rate ratio = 0.76; P=0.0502)]. In addition, 8 patients in the placebo group had serious adverse events of ventricular fibrillation compared with 0 patients in the ixmyelocel‑T group. These data suggest that reduction in ventricular arrhythmias may play a role in the clinical benefit observed with ixmyelocel-T multicellular therapy.

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