Pluristem and U.S. DOD Present Positive Data from Studies Testing PLX-R18 as a Prophylactic Treatment for ARS
Pluristem Therapeutics Inc. a leading regenerative medicine company developing novel placenta-based cell therapy products is presenting positive results from a series of studies of the company’s PLX-R18 cell therapy product conducted by the U.S. Department of Defense’s (DoD) Armed Forces Radiobiology Research Institute at the Uniformed Services University of the Health Sciences. The studies were designed to evaluate PLX-R18 as a potential prophylactic countermeasure against acute radiation syndrome (ARS) administered prior to radiation exposure.
These animal studies demonstrate that PLX-R18, administered 24 hours before radiation exposure, and again 72 hours after exposure, resulted in a significant increase in survival rates, from 4% survival rate in the placebo group to 74% in the treated group. In addition, the data show an increase in recovery of blood lineages (platelets, neutrophils, white blood cells, and lymphocytes) and a favorable safety profile. Furthermore, histopathological analysis and hematopoietic progenitor clonogenic assay of tissues collected show a significant increase in bone marrow cell numbers and improved regenerative capability into all blood lineages.
“We are very pleased with the positive results from the studies showing that PLX-R18 can potentially be used prophylactically, before exposure to radiation. We believe that this outcome is an important contribution to protect the armed and medical forces which may need to enter contaminated areas,” said Yaky Yanay, President and Chief Executive Officer of Pluristem. “It is Pluristem’s goal to provide the different federal agencies access to PLX-R18 that it may be used as a countermeasure both before and after radiation exposure in order to minimize hematological and other organ damage. We look forward to the continued development of this unique agent as an off the shelf product.”
In addition to the DoD study, PLX-R18 is also being evaluated by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), as a treatment following radiation exposure (ARS). Data from these studies demonstrated a significant increase in survival rates and enhanced neutrophil and lymphocyte recovery in radiation subjects. PLX- R18 cell therapy product candidate was granted an FDA orphan drug designation and an IND for the treatment of ARS. The animal studies were conducted following guidance from the U.S. Food and Drug Administration (FDA) relating to its animal rule pathway.