Pluri 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 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 for the treatment of graft failure, incomplete hematopoietic recovery following HCT, and the treatment of ARS. 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.”
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
See today’s best-performing stocks on TipRanks >>
Read More on PLUR:
- Pluri files $200M mixed securities shelf
- Pluri Announces Appointment of Entrepreneur Lorne Abony to Board of Directors
- Pluri signs three year $4.2M contract with NIAID
- 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