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Leif
10-14-2005, 11:43 AM
http://www.pharmalive.com//News/index.cfm?articleid=280202&categoryid=21


Osiris Launches a Phase II Clinical Trial for Severe Graft vs Host Disease

BALTIMORE--(BUSINESS WIRE)--Oct 12, 2005 - Osiris Therapeutics, Inc. announced today that it has received clearance from the United States Food and Drug Administration (FDA) to conduct a Phase II trial to evaluate the safety and effectiveness of its lead investigational stem cell drug, Prochymal(TM), for the rescue of patients with the most severe form of acute graft vs. host disease (GVHD). So called "treatment-refractory" GVHD occurs when patients fail to respond to conventional therapy and is fatal in more than 80% of cases.


Osiris made the decision to file for the Phase II trial after discussions with the FDA regarding positive preliminary results. "Based upon our early experience with the drug, it appears that these stem cells may be beneficial to critically ill patients who have failed other treatments for GVHD," said Gary Kleiner, MD, PhD, a pediatric immunologist at the University of Miami. The trial will be open to both pediatric and adult patients who have failed standard therapy for GVHD.


Graft vs. host disease is a life threatening complication of bone marrow transplantation and can affect the skin, liver, and intestines. Patients with any form of severe acute GVHD who meet the eligibility criteria may participate. For ethical reasons related to the severity of the disease, there will be no placebo arm and all patients will receive the active drug. Visit www.GVHDhelp.com for more information about the trial.

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