Pluri’s PLX-R18 Increases Blood Cell Counts and Reduces Need for Transfusions in a Phase I Study

Results Published in Nature Bone Marrow Transplantation

• Results support the development of PLX-R18 for hematologic acute radiation syndrome (H-ARS), currently under a $4.2 million contract with the U.S. National Institutes of Health
  
• PLX-R18 has the advantage of being an off-the-shelf product with no risk of graft vs. host disease (GvHD), reducing the need for blood product transfusions

HAIFA, Israel, Aug. 16, 2023 (GLOBE NEWSWIRE) -- Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) (“Pluri” or the “Company”), a leading biotech company that transforms cells into solutions that promote wellbeing and sustainability, today announced the publication of an article titled “Placental expanded mesenchymal-like cells (PLX-R18) for poor graft function after hematopoietic cell transplantation: A phase I study” in the peer reviewed journal Nature Bone Marrow Transplantation.

As described in the article, in a successful Phase I first-in-human study which achieved its primary endpoint, patients with incomplete hematopoietic recovery post-hematopoietic cell transplantation (HCT) were treated with escalating doses of Pluri’s cell therapy, PLX-R18. While patients received only two administrations of PLX-R18 during the first week, as compared to the standard of care which requires frequent and ongoing dosing, treated patients showed increased blood cell counts for as long as 12 months from administration, and a reduction in the need for blood transfusions. PLX-R18 was well tolerated with a favorable safety profile.

PLX-R18, a placental-derived cell therapy, has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of graft failure, incomplete hematopoietic recovery following HCT, and the treatment of ARS.

Low levels of blood cells (cytopenia) post-HCT can persist despite adequate engraftment of donor cells. Pluri’s PLX-R18 cells secrete a large array of hematopoietic factors which promote regeneration, maturation, and differentiation of hematopoietic cells and stimulate their migration to peripheral blood.

Dr. Joseph P. McGuirk, lead author of the published study and Schutte-Speas Professor, Hematologic Malignancies and Cellular Therapeutics at the University of Kansas Medical Center, commented, “This study suggested that PLX-R18 was able to increase blood cell counts and reduce the need for transfusions regardless of whether or not patients received hematopoietic growth factors, strengthening our conclusion that it was indeed PLX-R18, and not the other medications given to the patients, which contributed to the demonstrated efficacy. PLX-R18 shows promise in improving incomplete hematopoietic recovery post-HCT and has potential in other condition where cytopenia is a problem, for example, after CAR-T therapy.”