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Osiris Therapeutics completes patient enrollment in first worldwide Phase III stem cell trial.

Osiris Therapeutics, Inc., Columbia, MD, announced 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 after bone marrow transplantation. Prochymal is the company's proprietary formulation of adult mesenchymal stem cells (MSCs) designed to provide therapeutic benefit by controlling inflammation, promoting tissue regeneration, and preventing scar formation.

The 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 US, Canada, United Kingdom, Spain, Italy, Australia, Germany and Switzerland. The company says the three top enrolling sites in the study are the Fred Hutchinson Cancer Research Center in Seattle, WA, the M.D. Anderson Cancer Center in Houston, TX, and the Karmanos Cancer Institute in Detroit, MI.

In total, 168 patients were treated in the US, 31 in Canada, 27 in Europe, and 18 in Australia. A total of 27 pediatric patients were enrolled. The last patient is expected to complete the trial by May 29th, 2009.

The Phase III trial is evaluating the safety and efficacy of Prochymal in conjunction with standard care for treatment of patients who have failed to respond to corticosteroid treatment for acute GvHD. Patients were randomized to either Prochymal or placebo at a 2:1 ratio. GvHD assessments performed according to the International Bone Marrow Transplant Registry (IBMTR) were used in the trial to detect improvements in subjects treated with Prochymal. The key end points of the trial are complete response, at both 100-day and 180-day survival.

The company is also investigating the use of Prochymal as a first line agent for acute GvHD in a 184 patient Phase III trial and as a treatment for Crohn's disease in a 270-patient Phase III trial.

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

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Publication:Transplant News
Date:Dec 1, 2008
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Next Article:DOR BioPharma receives Orphan Drug designation from Australian agency to use orBec as treatment for GI GvHD.

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