Pluristem Therapeutics Inc. announced that it has concluded a positive meeting with the U.S. Food and Drug Administration (FDA) regarding the ongoing development of PLX-R18 for the treatment of Acute Radiation Syndrome (ARS). The FDA provided Pluristem with feedback on the progress and data collected on PLX-R18 to date and gave guidance towards advancing the development of PLX-R18 with respect to the treatment of ARS. The meeting also included representatives from the U.S. National Institute of Allergy and Infectious Diseases (NIAID) and the U.S. Biomedical Advanced Research and Development Authority (BARDA). PLX-R18 has been studied in Phase I and II-equivalent studies conducted and funded by NIAID via the FDA Animal Rule Pathway. Results from these studies showed that PLX-R18 supports the recovery of the bone marrow and increases survival rates. PLX-R18 has been granted an Investigational New Drug application (IND) and an orphan drug designation by the FDA for the treatment of ARS. ARS involves severe, potentially lethal damage to the bone marrow’s ability to produce blood cells, as well as to other systems and organs. Severe damage to bone marrow renders victims vulnerable to life-threatening hemorrhage, infection and anemia.