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Pluristem Therapeutics Inc. announced it has advanced its Phase I trial of PLX-R18 cells to treat insufficient hematopoietic recovery following hematopoietic cell transplantation (HCT) by contracting with a leading global clinical research organization (CRO).
The trial received clearance from the U.S. Food and Drug Administration earlier this year and enrollment is planned to begin in the coming months. The multi-center, open-label, dose-escalating Phase I trial will evaluate the safety of intramuscular injections of PLX-R18 cells in 30 patients with incomplete hematopoietic recovery persistent for 6 months or more after HCT.
“Data from this trial will inform the potential of PLX-R18 to treat a wide range of indications including blood cancers and radiation therapy-related blood diseases. The CRO we chose has extensive experience working with leading pharmaceutical and biotech companies to successfully manage clinical trials. We are excited to move forward to bring clinical sites online and begin enrolling patients,” said Pluristem Chairman and CEO Zami Aberman.
Data from multiple preclinical studies conducted by world-class research institutions, including the U.S. National Institutes of Health and Hadassah Medical Center, have shown that PLX-R18 cells secrete a range of specific proteins that support the regeneration of bone marrow and the recovery of its ability to produce normal amounts of all three blood cell types. PLX-R18 is designed to be administered without matching, and using a standard syringe to inject the cells intramuscularly.
