FDA clears Pluristem radiation treatment for emergency use

Pluri

30/04/2018 12:00

By Tova Cohen
    HAIFA, Israel, April 30 (Reuters) - Pluristem Therapeutics
Inc  PSTI.O , 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."
    PLX-R18 is injected into the muscle twice, a week apart.
    It is designed to treat bone marrow that is unable to
produce enough blood cells due to a variety of causes, including
ARS and certain cancers or cancer treatments.
    "We think that the everyday use of the compound will be for
bone marrow failure of any cause," Eisenkraft said. 
    Pluristem said its cells can be administered to patients
without the need for tissue matching. One placenta makes 20,000
treatments.
    Pluristem is conducting advanced Phase III trials in the
United States and Europe of another product, PLX-PAD, to treat
patients with the end-stage of peripheral artery disease, to
prevent the need for amputation.
    "In Europe, we are hoping to open data at the end of 2019
and in the U.S. a year later," co-CEO Zami Aberman said.
    That treatment has also been approved for a Phase III trial,
to begin in the next few months, in patients with the most
common form of hip fracture, in which the cells are injected
during surgery, he said. 

 (Reporting by Tova Cohen, editing by Louise Heavens)
 ((tova.cohen@thomsonreuters.com; +972-9-899-0222; Reuters
Messaging: tova.cohen.thomsonreuters.com@reuters.net))