During a press conference at the American College of Cardiology’s (ACC) 65th Annual Scientific Session, Vericel Corp (NASDAQ:VCEL) presented the Phase 2b results of its ixCELL-DCM clinical study, which relates to ixmyelocel-T in patients with heart disorders.
Substantial reduction in adverse events
The company reported that its stem cell therapy substantially reduced the deaths and hospitalisation among those patients, who had progressed to advance stage of heat failure. Overall, the company noted that its therapy is effective in delaying the need of heart transplants in heart failure patients.
The study was aimed to provide a comparison in between the effectiveness of the company’s stem cell therapy and placebo. The study comprised of 109 patients, who had advanced ischemic heart failure and had found all the optimal medical and device therapies ineffective.
After one year of trial study, the results showed that Vericel’s therapy showed a 37% fall in adverse events versus placebo. These adverse events included death, heart-related hospitalisation and unplanned clinical visits stemming from heart failure.
Effective against placebo
The detailed report follows the company’s announcement last month when it had said the successful completion of its clinical study. Alongside presenting the results at the scientific meeting in Chicago, the company has also disclosed the results in the Lancet medical journal.
Patients treated with the company’s ixmyelocel-T therapy resulted in just two deaths when compared to 7 deaths in the placebo group. Similarly, 38% of the patients receiving the company’s therapy required hospitalisation against 47% in placebo group. Meanwhile, the study failed to meet the secondary goals of the trial, which included higher efficiency of heart pumping or six-minute walking distance.
Lead investigator and chief of cardiology at Cedars-Sinai Heart Institute, Dr. Timothy Henry, stated that the therapy should undergo larger trials to prove its ability to counter heart disorders. He cited the results as an extremely significant milestone for both the company and the patients.
The stock of Vericel Corp (NASDAQ:VCEL) bounced back by 4.57% to $3.72 during the previous trading session.