Osiris completes enrollment in Phase III GVHD trial

Dec 05, 2008 (Datamonitor via COMTEX)

Osiris Therapeutics, a stem cell therapeutic company, has completed patient enrollment in its Phase III pivotal trial evaluating Prochymal for the treatment of steroid-refractory acute graft versus host disease.

This double-blinded, placebo controlled trial will assess safety and efficacy of Prochymal over a six-month period. A total of 244 patients were enrolled at 72 leading bone marrow transplant centers across the US, Canada, the UK, Spain, Italy, Australia, Germany and Switzerland.

In total, 168 patients were treated in the US, 31 in Canada, 27 in Europe, and 18 in Australia. A total of 27 pediatric patients were enrolled. The last patient is expected to complete the trial by May 29, 2009.

Prochymal is a proprietary formulation of adult mesenchymal stem cells designed to provide therapeutic benefit by controlling inflammation, promoting tissue regeneration, and preventing scar formation.

Osiris and Genzyme have previously announced a strategic alliance for the development and commercialization of Prochymal. Under the terms of the agreement, Osiris will commercialize Prochymal in the US and Canada, and Genzyme will commercialize the treatment in all other countries.

Moya Daniels, study director for the steroid-refractory graft versus host disease (GVHD) program at Osiris, said: "On behalf of everyone at Osiris, I would like to offer our sincere appreciation to the patients, their families, and all of the outstanding healthcare professionals who participated in this historic event. We look forward with great anticipation to the results of this landmark stem cell trial and the opportunity to make a positive difference in the care of transplant patients everywhere."