Findings pave the way to potentially use PLX-R18 to support hematological recovery following radiotherapy or chemotherapy
Data focuses on 12 additional NHPs that were exposed to lower radiation levels
HAIFA, ISRAEL, JULY 26, 2017— Pluristem Therapeutics Inc. (NASDAQ: PSTI) (TASE: PSTI), a leading developer of placenta-based cell therapy products, today presented new data at the RITN (Radiation Injury Treatment Network) conference from a recent study evaluating PLX-R18 as a treatment for Acute Radiation Syndrome (ARS).
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.
“There is a crucial need for a therapy to effectively treat populations in case of nuclear or radioactive incidents. These positive results strengthen our confidence in the safety profile and treatment potential of PLX-R18 for different levels of radiation exposure. These new findings, showing improvement in the hematologic system at lower radiation levels, suggest that PLX-R18 has the potential to treat the broader population exposed to different levels of radiation and might also be used for additional indications such as mitigating the negative effects of cancer treatments like chemotherapy,” said Yaky Yanay, president and Co-CEO of Pluristem. “With the knowledge that applications of PLX-R18 could go far beyond treating victims of nuclear incidents, we are one step closer to fulfilling our goal of providing better treatment options for millions of patients worldwide.”
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.