Israel's Pluristem Therapeutics Inc presented last week first trial results of a new vaccine, first of its kind, produced from placenta cells donated by Israeli women and was successful in reducing radiation-related damages in animals during trial.
The trials continue but the vaccine has already sparked the interest of the U.S. Army, which is considering administering it to soldiers deployed to nuclear radiation zones.
This product, named PLX-R18, also includes stem cells produced from placentas donated by Israeli women. The radiation therapy trials are performed only in animals.
These animal studies, conducted by the U.S. Department of Defense Armed Forces Radiobiology Research Institute 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.
High radiation exposure
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 and showed to be safe in animals that were not exposed to radiation, indicating the ability to provide immediate treatment without the need to assess the degree of radiation exposure.
PLX-R18 cell therapy product candidate was granted an FDA orphan drug designation and an IND for the treatment of ARS - which already allows Pluristem to treat victims exposed to high levels of radiation during a nuclear event such as an atomic bomb, a nuclear reactor leak or a natural disaster, even before receiving full marketing approval.