Clinical Trials Resource Center

New Medical Therapies™

Graft-Versus-Host Disease (GVHD)

Patient Medical Areas

November 20, 2006

Osiris announced positive results from a phase II trial of Prochymal for the treatment of Graft vs. Host disease (GVHD). This trial enrolled 32 subjects who were divided into two groups. In addition to standard of care, subjects received two infusions of Prochymal, a low dose (2 million cells per kilogram) or a high dose (8 million cells per kilogram) three days apart, at the onset of moderate to severe (grades II-IV) GVHD. Treatment was well tolerated at both dose levels and through repeated dosing. No serious adverse events were reported. Complete response was seen in 74% of the subjects and the overall response rate was 94%. In the sub-population of subjects with gastrointestinal GVHD, 67% had a complete response and the overall response rate was 89%. In the sub-population of the subjects with the dermatological form of GVHD, 85% had a complete response and the overall response rate was 100%. Osiris is currently evaluating Prochymal in a phase III trial for this indication.

January 10, 2005

DOR BioPharma reported top-line results from a phase III trial of orBec (oral beclomethasone dipropionate), for the treatment of intestinal Graft-versus-Host Disease (iGVHD). The results indicate that orBec failed to meet its primary endpoint, significant improvement in time to treatment failure through day 50 vs. placebo (p=0.1177), nor was the treatment failure rate at 50 days statistically significant (p=0.0515). The drug did achieve significance in several secondary endpoints, including time to treatment failure at day 80 (p=0.0226), treatment failure rate at day 80 (0.0048), and mortality rate 200 days post transplant (p=0.006). The randomized, double-blind, placebo-controlled, multi-center clinical trial enrolled 129 post-bone marrow transplant patients, who received high-dose prednisone plus orBec or placebo for 10 days. If initial response was noted after 10 days, prednisone was rapidly tapered and subjects continued to receive orBec or placebo through day 50.

June 9, 2003

Isotechnika reported positive results from a phase IIa trial investigating ISA247, an immunosuppressive for the use in kidney transplants. Results showed that all of the primary and secondary endpoints of the study were achieved. Data demonstrated that stable kidney transplant subjects on ISA247 experienced no change in kidney function when compared to subjects taking cyclosporine. In addition, data also demonstrated that ISA247 achieved a level of immunosuppression comparable to cyclosporine at one-third the blood drug concentration. One of the secondary endpoints, the incidence of graft rejection, was designed to monitor safety parameters in kidney transplant patients receiving ISA247. The open label, randomized, multi-center study enrolled 132 subjects at twenty sites in Canada and the United States.

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