- Israeli clinical sites will join an ongoing U.S. Phase I trial
- Hadassah Medical Center and Rambam Hospital have cleared the trial and recruitment is set to begin
Pluristem Therapeutics Inc. (PSTI) (PSTI), a leading developer of placenta-based cell therapy products, announced today that it received approval from Israel’s Ministry of Health to initiate a Phase I trial studying the company’s PLX-R18 cell therapy as a treatment for insufficient hematopoietic recovery following hematopoietic cell transplantation (HCT). As previously announced, the trial was also approved by the U.S. Food and Drug Administration (FDA) and recruitment is ongoing in the United States. Up to 30 patients will be recruited in total from the United States and Israeli trial sites. Ethics committees at both Hadassah Medical Center and Rambam Hospital in Israel have cleared the trial and recruitment can begin in both hospitals.
“We’re very pleased with the Israeli Ministry of Health’s vote of confidence in our innovative therapies and efforts to provide treatments for a range of hematopoietic conditions, including insufficient recovery from hematopoietic stem cell transplants,” stated Zami Aberman, Pluristem’s Co-CEO and Chairman. “Hadassah Medical Center and Rambam Hospital are well known for their groundbreaking treatments and we are happy for this collaboration. Previous studies with PLX-R18 cells have yielded promising results, which we believe suggest that our cells can improve patient outcomes.”
Pluristem’s PLX-R18 cells are in late-stage development as a treatment for acute radiation syndrome (ARS) and the program is supported by the U.S. National Institutes of Health (NIH), which is conducting the trials. The cells are also being studied by the U.S. Department of Defense and the Fukushima Medical University in Japan. Pluristem recently reported a new granted patent to cover PLX-R18 cells in additional indications related to the bone marrow’s inability to produce blood cells, including autoimmune diseases, genetic disorders, chemotherapy, and radiation therapy.
Bone Marrow Failure and HCT
Bone marrow failure is the inability of bone marrow to produce sufficient numbers of platelets, white or red blood cells. This inability may result in serious illness or death, because these cells are necessary to prevent hemorrhage, infection or severe anemia. Bone marrow failure can be caused either by medical conditions such as aplastic anemia, myelodysplastic syndrome, hematologic malignancies, or as a side effect of radiation or chemotherapy cancer treatment. The incidence of bone marrow failure resulting from these conditions varies widely, but is increasing.
The only known cure for bone marrow failure is HCT, although supportive therapies and treatments can reduce symptoms and prolong life for some patients. The hematopoietic cells for HCT can come from a donor or from the patient, and can be harvested from peripheral blood, bone marrow or umbilical cord blood. Transplant patients require extensive care and monitoring, and sometimes need intensive treatment for complications. In cases of incomplete engraftment, blood cell counts are insufficient, causing the patient to be at high risk of severe or lethal complications. In severe cases, the patient may need to undergo the arduous and dangerous process of a second transplant.
PLX-R18 is Pluristem’s second cell therapy product in development. It is designed to treat bone marrow that is unable to produce enough blood cells due to a variety of causes including ARS, certain cancers or cancer treatments, or immune-mediated bone marrow failure. PLX-R18’s first animal studies in ARS were performed in collaboration with Prof. Gorodetsky at Hadassah Medical Center. Further preclinical data from trials conducted by the NIH, Hadassah, the Charite in Berlin and other prominent research institutions have shown that PLX-R18 cells secrete a range of specific proteins that trigger the regeneration of bone marrow hematopoietic cells, thereby supporting the recovery of blood cell production. Pluristem is currently enrolling patients in a U.S. Phase I trial of PLX-R18 in incomplete bone marrow recovery following HCT and is preparing for a pivotal trial in ARS.
About Pluristem Therapeutics
Pluristem Therapeutics is a leading developer of placenta-derived cell therapy products with patented PLX (PLacental eXpanded) cells entering late-stage trials in several indications. Our PLX cell products each release a different range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage. The cells are grown using the Company’s proprietary 3D expansion technology and can be administered to patients without tissue matching or immunosuppression. Pluristem has Company-owned and operated, GMP-certified manufacturing and research facilities, a strong intellectual property position, and strategic relationships with major research and U.S. government institutions.