Full Press Release Details
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.”
Pluri’s Chief Medical Officer Nitsan Halevy added, “These results reinforce PLX-R18’s role as a potent potential therapy for hematological disorders, encompassing its proposed application in treating acute radiation syndrome. The publication of these findings in the esteemed Nature BMT journal, along with the backing of NIAID, significantly bolsters our H-ARS program and advances us toward the goal of marketing authorization. As a groundbreaking, first-in-class solution, PLX-R18’s capacity to augment hematopoietic system recovery and effectively manage diverse cytopenia holds immense promise.”
Safe Harbor Statement
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluri is using forward-looking statements when it discusses the potential benefits of PLX-R18, that PLX-R18 shows promise in improving incomplete hematopoietic recovery post-HCT and has potential in other condition where cytopenia is a problem, that the study results reinforce PLX-R18’s role as a potent potential therapy for hematological disorders and advances it toward the goal of marketing authorization. These forward-looking statements and their implications are based on the current expectations of the management of Pluri only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements about Pluri: changes in technology and market requirements; Pluri may encounter delays or obstacles in launching and/or successfully completing its clinical trials, if necessary; its products may not be approved by regulatory agencies, its technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; it may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with its processes; its products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; its patents may not be sufficient; its products may harm recipients or consumers; changes in legislation with an adverse impact; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluri to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluri undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluri reference is made to Pluri’s reports filed from time to time with the Securities and Exchange Commission.