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Pluristem -Â Model PLX-R18 - Cells Release Combination of Therapeutic Protein
PLX-R18 cells release a combination of therapeutic proteins in response to a damaged or poorly functioning hematopoietic system; this system creates the blood cells that protect us from infection, uncontrolled bleeding and anemia. PLX-R18 is currently in a Phase I clinical trial to treat incomplete hematopoietic recovery following Hematopoietic Cell Transplantation (HCT) and in development to treat Acute Radiation Syndrome (ARS).
PLX-R18 cell therapy was granted an orphan drug designation by the FDA for the treatment of graft failure, incomplete hematopoietic recovery following HCT and ARS. The Orphan Drug Act provides for granting special status to a drug or biological product, to treat a rare disease or condition. The benefits of achieving Orphan Drug Designation include close guidance by the FDA, which may accelerate the path to potential marketing approval, orphan drug grants, tax credits, and 7-year market exclusivity upon marketing approval.
The FDA has also cleared Pluristem’s Investigational New Drug (IND) application for PLX-R18 in the treatment of ARS. The IND allows Pluristem to treat victims who may have been acutely exposed to high dose radiation due to nuclear attack or accident.
PLX-R18 is also being evaluated in preclinical studies to explore its therapeutic potential to treat a variety of other hematologic indications.