Health knowledge made personal
Join this community!
› Share page:
Go
Search posts:

Osiris Therapeutics, Inc. (NASDA ...

Posted Nov 10 2008 4:22pm

Osiris Therapeutics, Inc. (NASDAQ:OSIR) announced that Prochymal has received Fast Track designation from the U.S. Food and Drug Administration (FDA), expediting development of the stem cell therapy as a first-line agent for acute Graft versus Host Disease (GvHD). A Phase III pivotal study for this indication was initiated in November and is now actively enrolling patients.

GvHD is a T-cell mediated inflammatory process that results in high levels of pro-inflammatory chemical signals called cytokines.  Prochymal is a preparation of mesenchymal stem cells specially formulated for intravenous infusion. The stem cells are obtained from the bone marrow of healthy adult donors.

Osiris Therapeutics Receives FDA Fast Track Status For Prochymal As First-Line Treatment For Acute GvHD

Post a comment
Write a comment: