BIO 300: a promising radiation countermeasure under advanced development for acute radiation syndrome and the delayed effects of acute radiation exposure

Abstract

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.

Metabolomics-based predictive biomarkers of radiation injury and countermeasure efficacy: current status and future perspectives

“…BIO 300 is a promising, new radiation injury mitigative agent under advanced development for H-ARS and DEARE, as well as for select oncologic indication(s) (e.g., nonsmall cell lung cancer (NSCLC)) [87] . The active pharmaceutical ingredient (API) in BIO 300 is synthetic genistein.…”

“…Efficacy following oral administration, lack of clinical side effects, drug storage at room temperature, and intended dual use (radiation countermeasure and anti-cancer agent) makes BIO 300 an optimal agent for civilian and military use. There are several ongoing studies using various animal models to identify biomarkers of efficacy and dose conversion for BIO 300 [87] . Studies of metabolomics with BIO 300 in murine and NHP models are discussed below.…”

Isoflavone research towards healthcare applications

“…200 nm. The synthetic genistein preparation BIO 300 is presently the subject of two investigational new drug (IND) applications at the FDA [73][74][75] .…”

Repurposing Pharmaceuticals Previously Approved by Regulatory Agencies to Medically Counter Injuries Arising Either Early or Late Following Radiation Exposure

“…Thus, there is a serious need for government agencies, academicians, and corporate entities to make a joint effort to get multiple agents that can be used either before or after irradiation approved for each indication in the shortest possible time. There are several promising radiation countermeasures under investigation for regulatory approval for ARS and DEARE ( Singh et al, 2017a ; Singh et al, 2017b ; Singh and Seed, 2017 ; Singh and Seed, 2020a ).…”