Pluri’s PLX-R18 optioned by NIH for $1.4M 2nd year budget

Pluri announced the U.S. National Institute of Allergy and Infectious Diseases – NIAID -, part of the National Institutes of Health – NIH -, has exercised its option for year two of the three-year $4.2M contract it entered into with Pluri in July 2023. During the 12 months from July 1, 2024 through June 30, 2025, the NIAID will provide $1.4M for the company to manufacture the PLX-R18 cell therapy and to conduct both in vitro and in vivo studies to develop PLX-R18 as a potential novel treatment for hematopoietic complications of the acute radiation syndrome, or H-ARS. H-ARS is caused by exposure to life-threatening amounts of ionizing radiation. The FDA previously approved an Investigational New Drug application for PLX-R18 for the treatment of H-ARS in the case of nuclear or radiological or incidents and granted it Orphan Drug Designation. PLX-R18 has been safely tested in both humans and animals. Prior studies demonstrated that PLX-R18 administered to animals after radiation exposure for H-ARS significantly increased survival rates from 29% in the control group to 97% in the treated group. Studies conducted by the DoD have shown that PLX- R18 resulted in a significant increase in survival rates, from 4% survival in the placebo group to 74% in the treated group and a significant increase in recovery of white blood cell, platelet, neutrophil and lymphocyte counts. PLX-R18 was tested in humans with incomplete hematopoietic recovery following hematopoietic cell transplantation and was well tolerated with a favorable safety profile. Patients treated with PLX-R18 showed an increase in all three blood cell types.