Under the expanded access program, children two months to 17 years in age inclusive with Grades B-D acute graft versus host disease (GVHD) not responsive to steroids are eligible for treatment.
Prochymal is a formulation of adult mesenchymal stem cells designed to provide therapeutic benefit by controlling inflammation, promoting tissue regeneration, and preventing scar formation.
Previously, Osiris and Genzyme have 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.
Andrew Daly, clinical professor, department of medicine and oncology at the University of Calgary, Canada, said: The results for Prochymal in pediatric patients with severe GVHD have thus far been very encouraging, and as a participating principal investigator in the Phase III trial for steroid-refractory GVHD, my experience treating patients with Prochymal has been a positive one.
With the implementation of this expanded access program, Osiris confirms its global commitment to the field of GVHD, a disease which is a significant unmet medical need.