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news.Osiris Therapeutics has said that interim results for the company's Phase I trial evaluating Prochymal for the treatment of heart attack patients continued to demonstrate a strong safety profile and statistically significant improvement in heart function.
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The trial collected one-year magnetic resonance imaging (MRI) data on left ventricular ejection fraction (LVEF), which reflects the fraction of blood pumped out of a ventricle with each heart beat. Based upon the positive results from this 53-patient, double-blind, placebo-controlled trial, the company has received approval from the FDA to initiate a Phase II trial.
Randal Mills, president and CEO of Osiris, said: “This early stage trial exceeded our expectations for both safety and efficacy. These data support our preclinical results and suggest that in acute myocardial infarction, early treatment with Prochymal can alter the course of disease.”