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.
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