title: Biologics as countermeasures for acute radiation syndrome: where are we now?
abstract: Despite significant scientific advances toward the development of a safe, nontoxic and effective radiation countermeasure for acute radiation syndrome (ARS) over the past six decades, no drug has been approved by the US FDA. Several biologics are currently under development as radiation countermeasures for ARS, of which three have received FDA Investigational New Drug (IND) status for clinical investigation. Presently, two of these agents, entolimod (CBLB502) and HemaMax (recombinant human IL-12) are progressing with large animal studies and clinical trials. Neupogen (G-CSF, filgrastim) has recently been recommended for approval by an FDA Advisory Committee. Filgrastim, GM-CSF (Leukine, sargramostim), and PEGylated G-CSF (Neulasta) have high potential and well-documented therapeutic effects in countering myelosuppression and may receive full licensing approval by the FDA in the future. The former two biologics are available in the US Strategic National Stockpile (SNS) for use in the event of nuclear or radiological emergency. The Emergency Use Authorization (EAU) application for entolimod may be filed soon with the FDA. Biologics are attractive agents that are progressing along the path for FDA approval, to fill the unmet need for ARS countermeasures.
authors.affiliation: Uniformed Services University of the Health Sciences, F. Edward Hébert School of Medicine, Department of Radiation Biology , Bethesda, MD , USA.
authors.forename: Vijay K
authors.initials: VK
authors.lastname: Singh
authors.forename: Patricia L P
authors.initials: PL
authors.lastname: Romaine
authors.forename: Victoria L
authors.initials: VL
authors.lastname: Newman
mesh_terms: D054508:Acute Radiation Syndrome / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D000818:Animals; D001688:Biological Products / Q000627:therapeutic use*; D017277:Drug Approval / Q000331:legislation & jurisprudence; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000627:therapeutic use; D006801:Humans; D010455:Peptides / Q000627:therapeutic use; D011092:Polyethylene Glycols; D011837:Radiation-Protective Agents / Q000627:therapeutic use*; D011994:Recombinant Proteins / Q000627:therapeutic use
chemical_list: D001688:Biological Products; C528306:CBLB502; D010455:Peptides; D011837:Radiation-Protective Agents; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; C455861:pegfilgrastim; D011092:Polyethylene Glycols; C081222:sargramostim; D016178:Granulocyte-Macrophage Colony-Stimulating Factor; D000069585:Filgrastim
keywords: biologics; countermeasures; mice; nonhuman primates; radiation