U.S. National Institutes of Health to Fund $4.2 Million Contract to Advance Development of Pluri’s PLX-R18 in Conjunction with U.S. DoD as a Medical Countermeasure for Hematopoietic Acute Radiation Syndrome - Seite 2

Pluri will collaborate with Prof. Vijay K. Singh of AFRRI, a world-renowned expert in radiation treatments. His laboratory’s primary research interest is to develop radiation countermeasures for ARS.

“The current time calls for us to accelerate the development and accessibility of radiation treatments, especially as geopolitical instability rises, and nuclear power plants face the threat of warfare,” said Pluri CEO and President Yaky Yanay. “Through this strategic contract with NIAID, we believe that we can realize our mission of making PLX-R18 readily available for emergency preparedness. We look forward to collaborating with Prof. Singh and AFRRI to explore the potential of PLX-R18 as a uniquely, scalable treatment for H-ARS.”

Prof. Singh added, “PLX-R18’s potential as a medical countermeasure for H-ARS is supported by robust human and animal data, making it a unique asset for further investigation. I’m eager to commence our collaborative study with Pluri and have high expectations for results.”

Prior studies funded by the NIH/NIAID and conducted in accordance with the FDA’s Animal Rule pathway 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 (p<0.001). Studies conducted by the U.S. Department of Defense (DoD) have shown that PLX-R18, administered as a prophylactic measure 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 (log-rank test p< 0.0001). In addition, the data show a significant increase in recovery of white blood cells (p = 0.0047), platelets (p = 0.0070), neutrophils (p = 0.0003) and lymphocytes (p = 0.0025) counts compared to administration of vehicle, and a favorable safety profileⁱ. 

Additionally, PLX-R18 was tested in humans with incomplete hematopoietic recovery following Hematopoietic Cell Transplantation (HCT) and was well tolerated with a favorable safety profile. Patients treated with PLX-R18 showed an increase in all three blood cell types compared to the baseline with platelets (p<0.001), hemoglobin (p = 0.02) and neutrophils (p = 0.15) levels increasing, as early as 1 month following PLX-R18 administration and enduring up to 12 months following treatment, while experiencing a significant reduction in mean number of transfused units from a monthly 5.09 to 0.55 for platelets (p = 0.045) and 2.91 to 0 for red blood cells (p = 0.0005) over 12 months of follow-up.