OSIRIS THERAPEUTICS GETS FDA APPROVAL FOR STEM CELL DRUG

Osiris Therapeutics has received clearance from the FDA to conduct a Phase II trial to evaluate the safety and effectiveness of its lead investigational stem cell drug, Prochymal.

Prochymal is an intravenous formulation of mesenchymal stem cells that is currently being evaluated for safety and effectiveness in human clinical trials. The drug is prescribed for the most severe form of acute graft versus host disease (GVHD). So-called "treatment-refractory" GVHD occurs when patients fail to respond to conventional therapy and is fatal in more than 80 percent of cases.