Preliminary results of Phase III GvHD trials revealed

Osiris Therapeutics, Inc. has announced the preliminary results for two phase III trials evaluating Prochymal for the treatment of acute graft versus host disease (GvHD).

GvHD is believed to be the common complication of bone marrow transplantation, which is life-endangering complication without any approved treatment option as of now.

From News-Medical.Net:

Protocol 265 was designed to evaluate Prochymal as a first-line agent for the treatment of acute GvHD in combination with steroid therapy. The majority of patients in this trial were suffering from skin GvHD, which responded significantly better to steroids than had been previously reported in controlled trials. This high response rate to standard of care diminished the potential for Prochymal to demonstrate an effect.

In the more severe, steroid-refractory GvHD setting (protocol 280), the benefit of adding Prochymal to second-line therapy was evaluated. Prochymal approached statistical significance for the primary endpoint in the per-protocol patient population which is the group of patients that met all of the study protocol requirements, such as inclusion and exclusion criteria. Additionally, Prochymal significantly improved response rates to liver and gastrointestinal GvHD, for which there is currently no known reliable therapy. Notably, the Prochymal cohort had more severe GvHD (27% of Prochymal patients had grade D GvHD, the most severe form, vs. 16% of placebo patients,>

C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris Therapeutics, was of the view that further analysis is still very much required to gain a complete appreciation of the rigorous, double-blind, placebo-controlled trial results.

Osiris is expected to file an amendment with the FDA for broadening the entry criteria including severe GvHD of the liver, on the basis of steroid-refractory GvHD trial results.

Tags: acute graft versus host disease, bone marrow transplantation, GvHD, Prochymal, steroid, steroid therapy

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