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Biotech / Medical : Pluristem Therapeutics
PSTI 8.720+0.2%Aug 14 4:00 PM EDT
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From: ACAN4/30/2018 8:15:10 AM
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PSTI April 30

FDA clears Pluristem radiation treatment for emergency use


By Tova Cohen

HAIFA, Israel, April 30 (Reuters) - Pluristem Therapeutics Inc, a developer of placenta-based stem cell products, said the U.S. Food and Drug Administration has cleared the emergency use of its therapy to treat acute radiation exposure in a nuclear event.

Pluristem said it will start preparations to keep an emergency stock of PLX-R18 on hand for use in such events.

Full approval of the drug will depend on the results of a Phase III clinical trial. Pluristem said on Monday it is in discussions with the FDA and several U.S. agencies to clear the path for such a large final-stage study.

The U.S. National Institutes of Health's National Institute of Allergy and Infectious Diseases sponsored and completed a mid-stage study of PLX-R18 in the treatment of acute radiation syndrome (ARS) in animals via the FDA's "animal rule pathway" as ARS cannot be tested in humans. PLX-R18 will be provided up to 96 hours following radiation exposure.

It is also being studied by the U.S. Department of Defense to support the armed forces as a treatment prior to, or within the first 24 hours of radiation exposure.

"We are increasing the survival rate following high-level radiation exposure," Arik Eisenkraft, Pluristem's director of homeland defence projects, told Reuters. "We see improvement in all three blood lineages - red cells, white cells and platelets."
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