Pluristem Therapeutics Inc., founded in 2003 and based in Haifa, Israel, is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLacental eXpanded (PLX) cells and is entering late-stage trials in several indications. 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 (3D) expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
Acute Radiation Syndrome (ARS), also known as radiation poisoning, radiation sickness, and radiation toxicity is a range of health effects that occur within 24 hours of exposure to high doses of ionizing radiation.
The Japan Patent Office has granted Pluristem a patent for the treatment of ARS and its impact on the gastrointestinal tract. The patent titled “Methods for Treating Radiation or Chemical Injury” relates to intramuscular (IM) administration of adherent stromal cells, grown under 3D culturing conditions, for mitigating intestinal damage in patients that have been exposed to radiation or chemotherapy.
Pluristem’s PLX-R18 cells are in late-stage development as a treatment for ARS in a program conducted and funded by the U.S. National Institutes of Health (NIH) and are also being studied by the U.S. Department of Defense (DOD) and Fukushima University.
A PLX-R18 investigational new drug (IND) application for ARS was recently cleared by the U.S. Food and Drug Administration (FDA), allowing Pluristem to treat victims who may have been acutely exposed to high dose radiation due to nuclear attack or accident. Pluristem’s PLX-R18 ARS program has also received an orphan drug designation by the FDA.
“The patent is a particularly meaningful asset for our Company in Japan, due to recently published findings from pre-clinical studies conducted at Fukushima Medical University, showing that following radiation exposure PLX-R18 cells significantly increase survival rates, preserve GI stem cell activity, enhance the recovery of the GI system and prevent severe damage to the intestinal lining,” stated Pluristem Chairman and Co-CEO Zami Aberman.
“We believe PLX-R18 is the optimal therapy available today for acute radiation injury. ARS includes injury to multiple organs, with its lethality stemming from radiation-induced damage mainly to the bone marrow and GI tract. The Fukushima University studies demonstrate PLX-R18’s potential ability to treat multiple organs affected by ARS,” Aberman added.