OSIRIS RECEIVES FAST-TRACK STATUS FOR CROHN'S TREATMENT

Osiris Therapeutics announced that Prochymal has received FDA fast-track designation, which will expedite the development of the stem-cell treatment for Crohn's disease that does not respond to standard therapies. The company also received clearance to conduct a Phase III clinical trial using Prochymal to treat this resistant form of Crohn's disease. The Phase III program was developed in consultation with FDA and, if successful, will be the last phase of testing before the company seeks approval for Prochymal for Crohn's disease.

Osiris recently reported positive clinical trial results evaluating Prochymal for treatment resistant Crohn's disease and graft-versus-host disease (GVHD). In a Phase II study of Prochymal for the treatment of patients with moderate to severe Crohn's disease who had failed to respond to standard therapies, every patient evaluated experienced a reduction in Crohn's Disease Activity Index (CDAI). There was a statistically significant decrease in average CDAI scores of 105 points from 341 to 236 by day 28.

In a Phase II study of Prochymal for the treatment of acute GVHD, 94 percent of evaluable patients responded after receiving two infusions of Prochymal. The study found that patients were twice as likely to have total clinical resolution of their disease when Prochymal was added to steroid therapy, compared with reported results for steroids alone.

Crohn's disease is the second indication for which Osiris has obtained fast-track status and has advanced into Phase III trials. Osiris was the first company to receive fast-track status for a ready-to-use stem-cell treatment, according to the drugmaker. Prochymal is a preparation of mesenchymal stem cells specially formulated for intravenous infusion.