Osiris initiates Phase II trial of Prochymal for diabetes

The Juvenile Diabetes Research Foundation has provided $4 million in funding to support the development of Prochymal. The trial will evaluate the safety and efficacy of Prochymal in conjunction with standard of care in preserving insulin production in patients recently diagnosed with type 1 diabetes mellitus and enrolls unto 60 patients.

The primary endpoint of the trial will be the measurement of C-peptide produced during a mixed meal tolerance test in patients treated with Prochymal, compared to those receiving placebo.

Richard Insel, executive vice president of research at Juvenile Diabetes Research Foundation (JDRF), said: “The development of an immunomodulatory cell therapy that could address the underlying inflammatory and immunological dysregulation and preserve islet cell function would be groundbreaking. The safety and efficacy data for Prochymal warrants further evaluation in type 1 diabetes. We look forward to working with Osiris to develop new treatment options for patients with this debilitating disease.”