Osiris' Prochymal progresses to US Ph II trial

USA-based Osiris Therapeutics says that results at the one-year time point of a Phase I trial evaluating Prochymal, its preparation of mesenchymal stem cells, in heart attack patients, continued to demonstrate a strong safety profile and statistically-significant improvement in heart function. Based upon the positive results from this 53-patient, double-blind, placebo-controlled study, the company has received approval from the US Food and Drug Administration to initiate a Phase II evaluation. On the day of the news, February 26, shares in the firm rose 3.7% to $12.25.

In the trial, the Prochymal treatment group achieved a statistically-significant 5.2-point increase in left ventricular ejection fraction over baseline (p=0.021). The placebo group experienced a 1.8 point improvement in LVEF over baseline, which was not statistically significant. Patients with more severe myocardial infarction, defined as a baseline LVEF of 45 or less, demonstrated even greater effects. The Prochymal-treatment group showed a 6.5-point benefit one-year post-therapy, compared to a 1.9-point increase in the placebo group.

"This early-stage trial exceeded our expectations for both safety and efficacy," said C Mills, chief executive of Osiris. "These data support our preclinical results and suggest that in acute myocardial infarction, early treatment with Prochymal can alter the course of disease. Based on this encouraging data, we look forward to promptly advancing Prochymal in this exciting, multi-billion dollar market," he added.