Celyad’s cardiac stem cell treatment fails phase III clinical trials

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Celyad’s cardiac therapy C-Cure® failed to show a significant benefit in the CHART-1 phase III clinical study. C-Cure is an experimental treatment based on stem cells that produce new autologous heart muscle cells, which behave identically to those lost during infarction. Although the clinical endpoint was not reached for the entire study population, a significant benefit was observed in a subgroup representing 60% of the study’s population.

Dr. Christian Homsy, CEO of Celyad, commented: “For the first time in a randomized, double-blind, controlled, Phase III cell therapy study, a positive effect, consistent across all parameters tested, was observed for a substantial, clearly definable, group of heart failure patients. CHART-1 has allowed us to better define the patient population that would benefit from C-Cure®.”

Celyad will contact the European Medicine Agency concerning a marketing authorization application, based on the positive results seen in the highly clinically relevant group of patients. The company is now looking for a partnership to further develop and commercialize C-Cure®.

Investors responded firmly to the news, with Celyad shares shedding 40% of their value. Luckily, Celyad still has its promising immune-oncology platform to soften the blow of the now failed cardiology branch. All eyes are now on the company’s CAR-T technology.