Osiris Therapeutics reports preliminary Prochymal Phase III GvHD trials produce mixed results.
The company says key findings from the trials include:
* There was no statistical difference between Prochymal and placebo on the primary endpoints for either the steroid-refractory (35% vs. 30%, n=260) or the first-line (45% vs. 46%, n=192) GvHD trials.
* The primary endpoint for the steroid-refractory GvHD trial (durable complete response) for the per-protocol population approached statistical significance (40% vs. 28%, p=087, n=179)
* In patients with steroid-refractory liver GvHD, treatment with Prochymal significantly improved response (76% vs. 47%, p=026, n=61) and durable complete response (29% vs. 5%, p=0.046)
* Prochymal significantly improved response rates in patients with steroid-refractory gastrointestinal GvHD (88% vs. 64%, p=018, n=71)
* In pediatric patients, Prochymal showed a strong trend of improvement in response rates (86% vs. 57%, p=0.094, n=28).
Osiris says the majority of patients in Protocol 265 were suffering from skin GvHD, which responded significantly better to steroids than had been previously reported in controlled trials which 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. The company reports Prochymal approached statistical significance for the primary endpoint in the per-protocol patient population, which is the group of patients that met all the study protocol requirements, such as inclusion and exclusion data. In addition, Prochymal significantly improved response rates to liver and gastrointestinal HvHD, for which there is no known reliable therapy.
Based on the results of the steroid-refractory GvHD trial, Osiris says it plans to file an amendment with the US Food and Drug Administration (FDA) to the current expanded access program, broadening the entry criteria to include patients with severe GvHD of the liver.
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|Date:||Sep 1, 2009|
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