Medical Countermeasures

There are four United States Food and Drug Administration (US FDA)-approved
pharmacological countermeasures against external penetrating ionizing radiation for use outside
the clinic: Neupogen (G-CSF/filgrastim), Neulasta (PEGylated G-CSF/PEGfilgrastim), Leukine
(GM-CSF/sargramostin), and Nplate (synthetic TPO receptor agonist/romiplostim). Nine
radiation countermeasures for ARS have US FDA Investigational New Drug (IND) status,
meaning that they can be tested for safety in humans. These agents are 5-androstenediol (5-AED,
Neumune), AEOL-10150, myeloid progenitors, Entolimod (CBLB502), Ex-Rad (Recilib),
genistein (BIO 300), OrbeShield, HemaMax (rhIL-12), and PLX-R18. AFRRI has been involved
in the development of six of these nine agents. 5-AED and genistein were conceived as
countermeasures and initially developed at AFRRI. CLT-008, Entolimod, Ex-Rad, and PLX-R18
were initiated at private companies; AFRRI collaborated at early stages. AFRRI performed some
of the earliest work on cytokines and growth factors as radiation countermeasures which were
approved by FDA in due course of time. Such development led to inclusion of Neupogen,
Neulasta, and Leukine in the Strategic National Stockpile (Vendor Managed Inventory).

AFRRI continues an intensive program on the identification and development of radiation
countermeasures to be used by military and civilian personnel. This work depends on studies
aimed at understanding the mechanisms of radiation injury, countermeasure efficacy, and
identification and validation of biomarkers. AFRRI has been funded for initial development as
well as advanced development of some of these countermeasure candidates.”