Osiris cleared for Ph III Prochymal trial

Maryland, USA-based Osiris Therapeutics says that, following Food and Drug Administration approval, it has initiated a Phase III pivotal trial evaluating Prochymal, a preparation of mesenchymal stem cells, as a first line agent in the treatment of acute Graft versus Host Disease, a life threatening complication of bone marrow transplantation that currently has no approved treatment.

This trial marks the third indication for which Prochymal has advanced into Phase III testing. The primary endpoint of this pivotal trial includes remission rates and increased patient survival. These endpoints are supported by data from the company's Phase II trial for the same indication. Highlights from this 32-patient study include:

- 77% of patients experienced complete remission of GVHD within 28 days when treated with Prochymal;