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FDA Grants Pluristem Orphan Drug Designation for Its PLX-R18 Cell Therapy as Treatment for Acute Radiation Syndrome

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Pluristem’s ARS program is developed and funded by the U.S. National Institutes of Health and the U.S. Department of Defense, and is in preparation for a pivotal study

HAIFA, Israel, Oct. 19, 2017 — Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, announced today that the U.S. Food and Drug Administration (FDA) has granted the company an orphan drug designation for its PLX-R18 cell therapy for the prevention and treatment of acute radiation syndrome (ARS). [Read more…]

U.S. DOD to Conduct Studies of Pluristem’s PLX-R18 in a New ARS Project for Use Before Radiation Exposure

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• The DOD studies seek to test the effectiveness of PLX-R18 as a novel medical countermeasure for Acute Radiation Syndrome (ARS) prior to and within 24 hours of exposure to high levels of radiation
• The DOD studies will be conducted in parallel with the ongoing ARS project with the NIH

Pluristem TherapeuticsHAIFA, ISRAEL, August 16, 2017— Pluristem Therapeutics Inc. (NASDAQ: PSTI) (TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that a pilot study of the company’s PLX-R18 cell therapy will be initiated by the U.S. Department of Defense’s (DOD) Armed Forces Radiobiology Research Institute (AFRRI), part of the Uniformed Services University of Health Sciences (USU). The study will examine the effectiveness of PLX-R18 as a treatment for Acute Radiation Syndrome (ARS) prior to, and within the first 24 hours of exposure to radiation.  [Read more…]

Governments on Alert and Stockpiling Antidotes for Nuclear Accidents and Attacks

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Many governments, including the U.S. and Japan, are well aware of the dangers to their populations of exposure to high levels of radiation from nuclear accidents or dirty bomb  attacks. Whereas Japan’s population was recently exposed at Fukushima following the tsunami of 2011, the U.S. Department of Defense has been stockpiling acute radiation syndrome (ARS) countermeasures as a precaution for many years.

The recent escalation of tensions between North Korea and the U.S. may give the American government cause to up its investment in ARS antidotes. During a military parade on April 15th, North Korea displayed weapons including an intercontinental ballistic missile (ICBM) that could be capable of reaching the U.S. ARS may have just become a larger threat to health than it was just a few weeks ago. [Read more…]

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