Osiris Therapeutics says its final set of two-year results from a trial for Prochymal, its cutting-edge adult stem cell therapy, met its primary endpoint on safety. Prochymal demonstrated fewer adverse events compared to placebo, showed a drop in repeat hospitalizations, reduced incidents of cardiac arrhythmia and also resulted in a durable improvement in cardiac function. The placebo-controlled study enrolled 53 patients.
"This study adds convincing long-term data to the excellent safety profile of Prochymal, having now treated hundreds of patients in trials over the past decade," said C. Randal Mills, Ph.D., president and CEO of Osiris Therapeutics. "We are excited that Prochymal demonstrated strong evidence of efficacy beyond the best cardiac care available today. We are now advancing this program into a larger Phase II trial, focusing on patients with more severe heart damage."
Osiris, which is developing the therapy with Genzyme, recently completed enrollment in a Phase III trial of Prochymal for the treatment of steroid-refractory acute graft versus host disease. And in January the developer received clearance from the FDA to broaden its expanded access program for Prochymal.
- check out Osiris' release