Osiris: FDA grants fast-track status for third indication of Prochymal
December 07, 2007: 04:54 PM EST
SAN FRANCISCO, Dec. 7, 2007 (Thomson Financial delivered by Newstex) -
- Osiris Therapeutics Inc. (NASDAQ:OSIR) after Friday's closing bell
said the Food and Drug Administration has granted its stem-cell
therapy Prochymal fast-track status for treatment of acute graft
versus host disease, or GvHD.
GvHD is a T-cell mediated inflammatory process that results in high
levels
of pro-inflammatory chemical signals called cytokines, which cause
the unbalanced activation of certain immune cells that result in
tissue damage.
A Phase III pivotal study for this indication was initiated in
November and is enrolling patients, Osiris said.
The Columbia, Md.-based biotechnology company said this is the third
indication for Prochymal that has received a fast-track designation
and has advanced into Phase III trials.
The FDA established the fast-track designation to facilitate the
development and accelerate the pre-market review of treatments for
serious and life-threatening conditions, so that these products can
reach approval more rapidly.
In 2005, FDA granted Prochymal fast-track status for the treatment of
steroid refractory acute GvHD. In 2006, it was given the designation
for the treatment of Crohn's disease. These programs are also both
enrolling patients in Phase III registration trials, the company said.
The company's stock closed down 50 cents, or almost 4$, at $12.33.
Katherine Hunt
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StemCells subscribers may also be interested in these sites:
Children's Neurobiological Solutions
http://www.CNSfoundation.org/
Cord Blood Registry
http://www.CordBlood.com/at.cgi?a=150123
The CNS Healing Group
http://groups.yahoo.com/group/CNS_Healing
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