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 The studies were conducted by the U.S. Department of Defense’s Armed
Forces Radiobiology Research Institute.
The tests, conducted via the Food and Drug Administration's "animal
rule pathway" as ARS cannot be tested in humans, were designed to
evaluate Pluristem's PLX-R18 as a preventative treatment for ARS
before radiation exposure.
The studies demonstrate that PLX-R18, administered 24 hours before
radiation exposure and again 72 hours after exposure, resulted in an
increase in survival rates, from 4% in the placebo group to 74% in
the treated group, Pluristem said.
The data also showed an increase in recovery of blood platelets,
neutrophils, white blood cells and lymphocytes and a favorable
safety profile. Analysis of tissues collected showed an increase in
bone marrow cell numbers and improved regenerative capability, the
company said.
"We believe that this outcome is an important contribution to
protect the armed and medical forces which may need to enter
contaminated areas," Chief Executive Officer Yaky Yanay said.
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"It is Pluristem’s goal to provide the different federal agencies
access to PLX-R18 that it may be used as a countermeasure both
before and after radiation exposure in order to minimize
haematological and other organ damage."
The Department of Defense is conducting further studies.
PLX-R18 is also being evaluated by the National Institute of Allergy
and Infectious Diseases, part of the U.S. National Institutes of
Health, as a treatment following radiation exposure.
Last year, the FDA cleared the emergency use of Pluristem's therapy
to treat ARS in a nuclear event.
(In this story, the company corrects data in paragraph 4 to show
survival rate of 74% in treated group)
(Reporting by Tova Cohen; Editing by Mark Potter)
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