Stem Cell

Therapeutics company announces fast track designation for stem cell product

Published in Cancer Weekly, March 1st, 2005

Osiris Therapeutics, Inc., announced that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for Prochymal, an adult stem cell product formulated for the treatment of acute Graft vs. Host Disease or GVHD.

Osiris believes FDA's decision makes the company the first to receive Fast Track designation for a preformulated stem cell drug.

Prochymal, now entering phase II clinical trials, is a formulation of a specific type of adult stem cell that has the ability to modulate the immune system in a way that may benefit patients suffering from a variety of immunological problems.

This new approach may...

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Source: Cancer Weekly (2005-03-01)

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