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Thursday, October 19, 2017 1:04:58 PM
Oct. 19, 2017 12:59 PM ET|About: Pluristem Therapeutics...
(PSTI)|By: Douglas W. House, SA News Editor
The FDA designates Pluristem Therapeutics' (PSTI +2%) cell therapy PLX-R18 an Orphan Drug for the treatment of acute radiation syndrome.
PLX-R18 is designed to treat bone marrow that is unable to produce enough blood cells, a result of acute radiation exposure as well as other causes (e.g., chemo).
A Phase 1 study in patients with incomplete bone marrow recovery following hematopoietic cell transplant is currently is in process.
Among the benefits of Orphan Drug status in the U.S. is a seven-year period of market exclusivity for the indication, if approved.
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