New York, NY -- (SBWIRE) -- 09/14/2017 -- The United States Department of Defense (DOD) will fund a study of Pluristem's cell therapy PLX-R18 evaluating its use as an antidote for Acute Radiation Syndrome (ARS) when administered prior to, or within 24 hours of, exposure to deadly radiation. Studies will be led by the DOD's Armed Forces Radiobiology Research Institute (AFRRI) whose mission is to protect the U.S. military from ionizing radiation.
PLX-R18's development for ARS appears to be in the most capable hands. AFRRI provides the Joint Staffs and the Joint Task Force Commander with expert advice during response to a radiation incident. Research pioneered by AFRRI led to FDA approval of Neupogen® and Neulasta® as ARS countermeasures. Both are Amgen products and both are dual use products for ARS and for treating cancer patients who are exposed to radiation therapy and chemotherapy.
Blockbuster drugs, they had combined 2016 sales of over $5.4 billion. $157 million worth of Neupogen® was purchased and stockpiled in 2013 by the U.S. Biomedical Advanced Research and Development Authority (BARDA) in case of a nuclear attack or accident.
PLX-R18 could be next on the list of approved ARS countermeasures. It is already being evaluated by the National Institutes of Health (NIH), which is ready to move into a pivotal trial for PLX-R18 for use 24 hours after radiation exposure. The DOD's AFRRI is looking to use PLX-R18 as a preemptive measure.
The DOD would immediately administer Pluristem's cell therapy to U.S. military personnel stationed in Guam if PLX-R18 were approved today, I believe. This, given the recent threats hurled at the U.S. from North Korea. State and other government officials may do the same for their own constituents.
Hawaii just became the first state in the U.S. to prepare an official disaster management plan in case of a nuclear attack from North Korea. The state is planning for a worst-case scenario of having only 8-12 minutes for the public to take cover if a 15-kiloton nuclear weapon is dropped 1,000 feet over Hawaii. North Korea could land one in Hawaii in a mere 20 minutes.
Over 13,000 nuclear warheads are stockpiled or deployed around the world today by eight countries, not including North Korea, according to the Federation of American Scientists. With or without North Korea's threat, the need for an ARS prophylactic is clear. Nuclear proliferation is the reason.
Data published by the NIH from its own studies of PLX-R18 showed subjects who were exposed to high levels of radiation and then treated with PLX-R18 had a survival rate of 85%, compared to 50% in the untreated groups. PLX-R18 treats bone marrow that is unable to produce enough blood cells due to a variety of causes including ARS, certain cancers or cancer treatments, or immune-mediated bone marrow failure. Pluristem is conducting a U.S. Phase I trial for PLX-R18 in incomplete bone marrow recovery following hematopoietic cell transplantation, a procedure often used in cancer patients who have been exposed to radiation.
Superior safety results from the NIH studies indicate PLX-R18 is ideally suited for rapid deployment in large populations in case of a nuclear emergency because it can be administered without prior testing of individuals for their level of radiation exposure. This could be the key to why the DOD is evaluating it for preemptive or preventative use, before people are exposed to radiation.
While everyone hopes for a de-escalation of the rhetoric between North Korea and the U.S., on the upside, the situation may result in the U.S. becoming more prepared with ARS countermeasures that can also have dual use applications to help people suffering from cancer-related radiation exposure.
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About Ray Dirks
Ray Dirks came to Wall Street with Goldman, Sachs & Co. in 1963 where he was established as the leading insurance stock analyst dealing with institutional investors and high -net worth investors both in the U.S. and internationally. In 1973 Ray uncovered the biggest Ponzi scheme of the 20th century, the Equity Funding fraud. Over the years Ray has expanded his stock market research to include Healthcare Stocks and Special Situations. Ray has written two books, "The Great Wall Street Scandal" and "Heads You Win, Tails You Win", published by McGraw-Hill and Bantam Books respectively. He continues to provide research to institutions and individuals, and he manages money for some individual investors.
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