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"Positive Meeting" With FDA, NIH, BARDA On Acute Radiation Syndrome.

HAIFA, Israel, January 3, 2019 - Pluristem Therapeutics Inc. (NASDAQ:PSTI) announced it has concluded what it terms "a positive meeting" with the FDA regarding the ongoing development of PLX-R18 for the treatment of acute radiation syndrome (ARS).

The FDA offered feedback on the progress and data collected on PLX-R18 to date and gave guidance toward advancing the development of PLX-R18 with respect to the treatment of the condition.

ARS involves severe, potentially lethal damage to the bone marrow's ability to produce blood cells, as well as to other systems and organs.

Severe damage to bone marrow renders victims vulnerable to life-threatening hemorrhage, infection and anemia.

The meeting also included representatives from the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).

"We are pleased to have completed a positive meeting with the FDA and U.S. government agencies representatives, which we believe has provided us with a clear and efficient path towards advancing the development of PLX-R18, targeting approval in the treatment of ARS," said Co-CEO Yaky Yanay,. "For several years, we have cooperated with the NIAID, which has supported and conducted studies of PLX-R18 in ARS."

The studies demonstrated PLXR18's potential to increase survival rates after radiation exposure, as well as protect and regenerate the bone marrow's ability to produce blood cells, crucial for victims exposed to high levels of radiation.

Government agencies such as NIAID, the Department of Defense, and BARDA have shown interest in the company's novel regenerative medical countermeasure for radiation injuries.

PLX-R18 has been studied in Phase1 and 2-equivalent studies conducted and funded by NIAID via the FDA Animal Rule Pathway.

Results from these studies showed that PLX-R18 supports the recovery of the bone marrow and increases survival rates. The drug has been granted an Investigational New Drug application (IND) and an orphan drug designation by the FDA for the treatment of ARS.

PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage. The cells are grown using the company's proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.


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Title Annotation:Therapeutic Development
Publication:Stem Cell Business News
Date:Feb 4, 2019
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