Haifa’s Pluristem Therapeutics reported positive preliminary results on Thursday of its first Phase I, open-label study to evaluate the safety and efficacy of its PLX-R18 treatment in humans with incomplete hematopoietic recovery following Hematopoietic Cell Transplantation (HCT).Pluristem’s PLX-R18, a simple shot of placenta blood cell serum injected into the thigh, is meant to induce the body to create new blood cells, repopulating its blood system. Pluristem’s cells are grown using the company’s 3-D micro-environmental technology.The “18” in PLX-R18, according to company CEO and President Yaky Yanay stands for “chai,” life in Hebrew.“We believe that PLX-R18 affects the regeneration activity of the hematopoietic cells,” Yanay explained. “By supporting blood cell lineage’s recovery, this approach could be used to address a variety of hematological deficiencies. We intend to push forward the clinical development of PLX-R18 with the goal of establishing it as the new standard of care in the field.”Hematopoiesis is the process through which the body manufactures blood cells.An explanation of HCT on the Cancer Network explained it as “the intravenous infusion of hematopoietic stem and progenitor cells designed to establish marrow and immune function in patients with a variety of acquired and inherited malignant and nonmalignant disorders, nonmalignant acquired bone marrow disorders and genetic diseases associated with abnormal hematopoiesis and function.” This could include patients with leukemia, lymphoma, aplastic or sickle cell anemia, among others.HCT can also be used to support patients undergoing high-dose chemotherapy for the treatment of certain solid tumors, the network explained.However, HCT is not always without complications. Poor graft function can be a life-threatening challenge for some patients undergoing HCT.“Current standard-of-care treatments do not develop satisfactory blood count in some or all blood cell lineages,” a Pluristem press release explained. “Consequently, patients are vulnerable to bleeding and recurrent infections, and require repeated costly transfusions of blood products, which only provide a short-term effect.”Pluristem’s PLX-R18 aims to stimulate the regenerative potential of the bone marrow to enhance the production of all three blood cell lineages: hemoglobin, neutrophil and platelet counts. Current standard-of-care treatments target only one of the three lineages.The Pluristem study showed that around 60% of all patients exhibited improvements in all three blood cell lineages. Six out of 21 US- and Israeli-based patients became transfusion independent within six months. No patients went from being transfusion independent to transfusion dependent.All study participants were at least three months after the HCT procedure and had low blood counts in at least one blood cell lineage. They received either 1 million PLX-R18 cells/kg, 2 million cells/kg or 4 million cells/kg.After six months, PLX-R18 proved to have a favorable safety profile, as well.This is not the first study of the product, although it is the first human study.PLX-R18 was found effective in treating bone marrow failure from Acute Radiation Syndrome in a preclinical study conducted via the US Food and Drug Administration’s Animal Rule in collaboration with the US National Institutes of Health.
Pluristem’s placenta cells induce body to create new blood cells - study
Pluristem's PLX-R18 aims to stimulate the regenerative potential of the bone marrow to enhance the production of all three blood cell lineages: hemoglobin, neutrophil and platelet counts.
