Pluristem and U.S. Department of Defense Present Positive Data from Studies Testing PLX-R18 as a Prophylactic Treatment for Acute Radiation Syndrome

  • PLX-R18 demonstrated significant increase in survival rates and recovery of the three blood lineages
  • Data is jointly presented at the 2019 Radiation Injury Treatment Network (RITN) Workshop

HAIFA, Israel IJuly 31, 2019 I Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), 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.

About ARS
ARS results from exposure to high levels of radiation, as in the case of a nuclear accident or attack, and it may cause severe or fatal systemic effects such as injuries that hinder the bone marrow’s ability to produce blood cells and platelets, as well as other organs and systems within the body, increasing patients’ susceptibility to life-threatening hemorrhage, infection, and anemia.

About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product and is currently conducting late stage clinical 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 expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.

SOURCE: Pluristem Therapeutics

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