The change to the entry criteria will help ensure that the study includes the population most likely to benefit from a therapy designed to intervene in the early stages of the disease. To support expanding the age range in the trial, early, blinded data from the ongoing type 1 diabetes trial was submitted to the Food and Drug Administration (FDA) for review. Additionally, updated safety information on Prochymal from experience with pediatric patients in other indications, including the pediatric expanded access program for graft vs. host disease (GvHD), was submitted.
“We are proud to be working alongside the JDRF in this landmark trial to evaluate the role of mesenchymal stem cells in patients with type 1 diabetes,” said C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris Therapeutics. “Caring for kids with limited medical options is a very special part of life at Osiris and we take that responsibility seriously. The progress we are making in this clinical program is remarkable and would not be possible without our patients, clinical teams, and the FDA’s thoughtful and responsive assistance.”
