Introduction: There are no radioprotectors currently approved by the United States Food and Drug Administration (US FDA) for either the hematopoietic acute radiation syndrome (H-ARS) or for the acute radiation gastrointestinal syndrome (GI-ARS). There are currently, however, three US FDA-approved medicinals that serve to mitigate acute irradiation-associated hematopoietic injury.
Area covered: We present the current status of a promising radiation countermeasure, BIO 300 (a genistein-based agent), that has been extensively investigated in murine models of H-ARS and models of the delayed effects of acute radiation exposure (DEARE) and is currently being evaluated in large animal models. It is also being developed for the prevention of radiation-induced toxicities associated with solid tumor radiotherapy and is the subject of two active Investigational New Drug (IND) applications. We have included a listing and brief review of significant investigations of this promising medical countermeasure.
Expert opinion: BIO 300 is a leading radioprotector under advanced development for H-ARS and DEARE, as well as for select oncologic indication(s). Efficacy following oral administration (po), lack of clinical side effects, storage at ambient temperature, and intended dual use makes BIO 300 an ideal candidate for military and civilian use as well as for storage in the Strategic National Stockpile.
Keywords: Acute radiation syndrome; BIO 300; biomarkers; delayed effects of acute radiation exposure; estrogen receptor; radiation countermeasures.