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Findings pave the way to potentially use PLX-R18 to support hematological recovery following radiotherapy or chemotherapy
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Data focuses on 12 additional NHPs that were exposed to lower radiation levels
Pluristem recently announced positive data from a Phase II-equivalent study under the FDA Animal Rule demonstrating improved survival and hematological recovery of non-human primates (NHP) exposed to high levels of radiation. The study was conducted and funded by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH).
New data from the study focuses on 12 additional NHPs that were exposed to lower radiation levels than those in the initial study. In a radioactive or nuclear incident, many victims will suffer from health effects resulting from low radiation exposure and not necessarily from the more dire impact of exposure to high radiation levels. The findings suggest that even though low radiation exposure is not lethal, it can lead to serious hematological deficiencies and to long-term health problems that result from such damage.
Neutrophil, lymphocyte, and platelet counts of the 12 PLX-R18-treated subjects showed faster recovery than those of the study’s control group. This finding indicates that PLX-R18 could potentially be used as a treatment for additional indications relating to bone marrow deficiencies, such as those that may occur due to radiotherapy, chemotherapy, adverse drug reaction and some genetic conditions.
These new findings also strengthen the safety profile of PLX-R18 in subjects exposed to different levels of radiation and even to subjects not exposed to radiation at all. This is a critical factor in case of disasters where screening of victims for exposure levels would delay treatment and potentially reduce its efficacy.
In addition, a thorough analysis of the initial group of 24 NHPs exposed to high doses of ionizing radiation showed that PLX-R18 treatment shortened the length of time spent below severe blood count thresholds, thus avoiding serious infections, hemorrhaging, and anemia.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells and is entering late-stage trials in several indications. The cell products release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.
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.