Israel-based drug development company Pluristem Therapeutics has advanced its Phase I trial of PLX-R18 cells in collaboration with a clinical research organisation (CRO) to treat insufficient hematopoietic recovery following hematopoietic cell transplantation (HCT).
PLX-R18 cells eject proteins that regenerate bone marrow and allow it to redeem its ability to produce normal amounts of all three blood cell types.
The multi-centre, open-label, dose-escalating Phase I trial is designed to assess the safety of PLX-R18 cells, while being administered intramuscularly in 30 patients with incomplete hematopoietic recovery persistent for six months or more.
The trial received clearance from the US Food and Drug Administration (FDA) earlier this year and enrolment is planned to begin during the coming months.
Pluristem Chairman and CEO Zami Aberman said: “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.”
PLX-R18 can be administered without matching by using a standard syringe to inject the cells intramuscularly.
It is currently being studied in collaboration with the US National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) to explore its efficacy in treating the hematological syndrome of ARS.