Osiris Completes Enrollment in First Worldwide Phase III Stem Cell Trial

Osiris Therapeutics, Inc. announced that it has completed patient enrollment in its Phase III pivotal trial evaluating Prochymal for the treatment of steroid-refractory acute Graft versus Host Disease (GvHD), a life threatening complication of bone marrow transplantation.

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

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 United States, Canada, United Kingdom, Spain, Italy, Australia, Germany and Switzerland.

The three top enrolling sites in the study were the Fred Hutchinson Cancer Research Center in Seattle, Washington, the M.D. Anderson Cancer Center in Houston, Texas, and the Karmanos Cancer Institute in Detroit, Michigan.

"Completion of this study’s enrollment represents an outstanding accomplishment for the transplantation field,” said Paul Martin, M.D., of the Fred Hutchinson Cancer Research Center, Professor at the University of Washington and lead investigator for the trial.

“Steroid-refractory acute Graft versus Host disease poses one of the most serious and difficult-to-treat complications that can occur after bone marrow transplantation. Previous studies have not identified reliably effective treatments, and no drugs have been approved for this devastating disease. Transplant clinicians throughout the world now eagerly await results of this rigorous multicenter study."

In November, Osiris and Genzyme Corp. announced a strategic alliance for the development and commercialization of Prochymal. Under the terms of the agreement, Osiris will commercialize Prochymal in the United States and Canada, and Genzyme will commercialize the treatment in all other countries.