COLUMBIA, Md.--(BUSINESS WIRE)--Osiris Therapeutics, Inc. (NASDAQ:OSIR) announced today that Prochymal™ has received Fast Track designation from the U.S. Food and Drug Administration (FDA), expediting development of the stem cell therapy as a first-line agent for acute Graft versus Host Disease (GvHD). A Phase III pivotal study for this indication was initiated in November and is now actively enrolling patients.
This is the third 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, when in 2005, FDA granted Prochymal Fast Track status for the treatment of steroid refractory acute GvHD. In 2006, Prochymal was granted Fast Track status for the treatment of Crohn’s disease. Both these programs are enrolling patients in Phase III registration trials.
