Osiris Therapeutics received $2 million from the Juvenile Diabetes Research Foundation (JDRF) for progressing its mesenchymal stem cell (MSC) therapy into a Phase II study. The milestone payments were triggered by Osiris accomplishing certain clinical and regulatory goals including initiating patient treatments.
Prochymal is being tested in patients recently diagnosed with type 1 diabetes. “Our ultimate goal with this research is to develop a treatment that we could give a patient at the onset to safely halt progression of the disease and preserve enough islet-cell function to avoid the need for insulin administration all together,” explains Jay S. Skyler, M.D., a study investigator and professor of medicine and associate director of the Diabetes Research Institute at the University of Miami.
Prochymal is also currently in Phase III trials for graft vs. host disease and Crohn’s disease. “Because Prochymal has been shown to home to sites of inflammation and inhibit immune system attack in other disease states, we are very excited about evaluating its potential to alter the course of this debilitating condition,” remarks Kashif Latif, M.D., another study investigator for Osiris and medical director of the AM Diabetes and Endocrinology Center.
The Phase II trial is evaluating Prochymal in preserving insulin production in patients 18 to 30 years. It is designed as a double-blind, placebo-controlled, multicenter trial with a target enrollment of 60 patients, according to Osiris. The primary endpoint of the trial will be the measurement of C-peptide produced after glucose stimulation.