Positive Results Reported for Ixmyelocel-T in Heart Failure Trial

Patient-specific multicellular therapy reduces deaths and hospitalizations

Positive results have been announced from a phase 2b trial of ixmyelocel-T (Vericel Corporation) in patients with advanced heart failure due to ischemic dilated cardiomyopathy (DCM). The study met its primary endpoint of demonstrating 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 after treatment with ixmyelocel-T compared with placebo.

The incidence of adverse events, including serious adverse events, in patients treated with ixmyelocel-T was comparable with that in patients in the placebo group.

Ixmyelocel-T is a patient-specific, expanded multicellular therapy manufactured from the patient’s own bone marrow using a proprietary, automated, fully closed cell-processing system. This process selectively expands the population of mesenchymal stromal cells or, alternatively, activated macrophages, which are responsible for the production of anti-inflammatory and pro-angiogenic factors known to be important for the repair of damaged tissue. Ixmyelocel-T received an orphan drug designation from the FDA for use in the treatment of DCM.

The ixCELL-DCM trial was a randomized, double-blind, placebo-controlled phase 2b study designed to assess the efficacy, safety, and tolerability of ixmyelocel-T compared with that of placebo (vehicle control) when administered via transendocardial catheter-based injections to subjects with end-stage heart failure due to ischemic DCM who had no reasonable revascularization options (either surgical or percutaneous interventional) that were likely to provide a clinical benefit. A total of 114 patients were treated at 28 sites in the U.S.

Source: Vericel Corporation; March 10, 2016.

More Headlines

Renal cancer drugs are equivalent to placebo in adjuvant setting
Some subjects received doses 10 to 40 times higher than necessary
Progress costs money, industry finds
Drug treats hematologic malignancies
Experts find “moderate benefit” from screening high-risk individuals
Current reimbursement encourages doctors to prescribe higher-priced medications
Experts identify top priorities