Relevant Publications

Medical Countermeasures


Serebrenik AA, Verduyn CW, Kaytor MD. Safety, Pharmacokinetics, and Biomarkers of an Amorphous Solid Dispersion of Genistein, a Radioprotectant, in Healthy Volunteers. 2023;12(2):190-201. PubMed PMID: 36301689.

Singh VJ, Serebrenik AA, Fatanmi OO, Wise SY, Carpenter AD, Janocha BL, Kaytor MD.  The Radioprotectant, BIO 300, Protects the Lungs from Total-Body Irradiation Injury in C57L/J Mice. PubMed PMID: 36689635

Serebrenik AA, Verduyn CW, Kaytor MD. Safety, Pharmacokinetics, and Biomarkers of an Amorphous Solid Dispersion of Genistein, a Radioprotectant, in Health Volunteers.  Clinical Pharmacology in Drug Development. 2022. PubMed PMID: 36301689

Singh VJ, Fatanmi OO, Wise SY, Carpenter A, Nakamura-Peek S, Serebrenik AA, Kaytor, MD. A novel formulation of BIO 300 confers prophylactic radioprotection from acute radiation syndrome in mice. International Journal of Radiation Biology, 2021 Sep 28;1-10. PubMed PMID: 34553032

Cheema AK, Li Y, Singh J, Johnson R, Girgis M, Wise SY, Fatanmi OO, Kaytor MD, Singh VK. Microbiome study in irradiated mice treated with BIO 300, a promising radiation countermeasure. 2021;3(1):71. PubMed PMID: 34627406.

Landauer MR, Harvey AJ, Kaytor MD, Day RM. Mechanism and therapeutic window of a genistein nanosuspension to protect against hematopoietic-acute radiation syndrome. Journal of Radiation Research. 2019;60(3):308-317. PubMed PMID: 31038675

Jones JW, Jackson IL, Vujaskovic Z, Kaytor MD, Kane MA. Targeted metabolomics identifies pharmacodynamic biomarkers for BIO 300 mitigation of radiation-induced lung injury. Pharmaceutical Research. 2017;34(12):2698-2709. PubMed PMID: 28971289.

Jackson IL, Zodda A, Gurung G, Pavlovic R, Kaytor MD, Kuskowski MA, Vujaskovic Z. BIO 300, a nanosuspension of genistein, mitigates pneumonitis/fibrosis following high-dose radiation exposure in the C57L/J murine model. British Journal of Pharmacology. 2017;174(24):4738-50. PubMed PMID: 28963717.

Ha CT, Li XH, Fu D, Xiao M, Landauer MR. Genistein nanoparticles protect mouse hematopoietic system and prevent proinflammatory factors after gamma irradiation. Radiation research. 2013;180(3):316-25. PubMed PMID: 23952576.



Simone II CB,  Serebrenik AA, Gore EM, Mohindra P, Brown SL, Wang D, Chetty IJ, Vujaskovic Z, Menon S, Thompson J, Fine G, Kaytor MD, Movsas B. Multicenter Phase 1b/2a Clinical Trial of Radioprotectant BIO 300 Oral Suspension for Patients With Non-Small Cell Lung Cancer Receiving Concurrent Chemoradiotherapy. 2023. PubMed PMID: 37652301.

Kaytor MD, Serebrenik AA, Lapanowski K, McFall D, Jones M, Movsas B, Simone II CB, Brown SL. The radioprotectant nano-genistein enhances radiotherapy efficacy of lung tumors in mice. 2023;12(5):999-1010. PubMed PMID: 37323169.Jackson IL, Pavlovic R, Alexander AA, Connors CQ, Newman D, Mahmood J, Eley J, Harvey AJ, Kaytor MD, Vujaskovic Z. BIO 300, a nanosuspension of genistein, mitigates radiation-induced erectile dysfunction and sensitizes human prostate cancer xenografts to radiation therapy. International Journal of Radiation Oncology. 2019;105(2):400-409. PubMed PMID: 31175904.

Zhang J, Su H, Li Q, Li J, Zhao Q. Genistein decreases A549 cell viability via inhibition of the PI3K/AKT/HIF-1a/VEGF and NF-kb/COX-2 signaling pathways. Molecular Medicine Reports 2017;15(4):2296-2302. PubMed PMID: 28259980.

Fang Y, Zhang Q, Wang X, Yang X, Wang X, Huang Z, Jiao Y, Wang J. Quantitative phosphoproteomics reveals genistein as a modulator of cell cycle and DNA damage response pathways in triple-negative breast cancer cells. International Journal of Oncology. 2016;48(3):1016-28. PubMed PMID: 26783066

Liu X, Sun C, Liu B, Jin X, Li P, Zheng X, Zhao T, Li F, Li Q. Genistein mediates the selective radiosensitizing effect in NSCLC A549 cells via inhibiting methylation of the keap1 gene promoter region. Oncotarget. 2016;7(19):27267-79. PubMed PMID: 2702907

Thomas CG, Strom A, Lindberg K, Gustafsson JA. Estrogen receptor beta decreases survival of p53-defective cancer cells after DNA damage by impairing G(2)/M checkpoint signaling. Breast Cancer Research and Treatment. 2011;127(2):417-27. PubMed PMID: 206231

Inflammatory Lung Diseases

Rios CI, Cassatt DR, Hollingsworth BA, Satyamitra MM, Tadesse YS, Taliaferro LP, Winters TA, DiCarlo AL. Commonalities Between COVID-19 and Radiation Injury. Radiation Research. 2021;195(1):1-24. PubMed PMID: 33064832.

Gentile F, Aimo A, Forfori F, Catapano G, Clemente A, Cademartiri F, Emdin M, Giannoni A. COVID-19 and risk of pulmonary fibrosis: the importance of planning ahead. European Journal of Preventive Cardiology. 2020. PubMed PMID: 32551971

Spagnolo P, Balestro E, Aliberti S, Cocconcelli E, Biondini D, Della Casa G, Sverzellati N, Mahr TM. Pulmonary fibrosis secondary to COVID-19: a call to arms. Lancet Respiratory Medicine. 2020. PubMed PMID: 32422177

Mo X, Jian W, Su Z, Chen M, Peng H, Peng P, Lei C, Chen R, Zhong N, Li S. Abnormal pulmonary function in COVID-19 patients at time of hospital discharge. European Respiratory Journal. 2020;55(6):2001217. PubMed PMID: 32381497

Background and Mechanism of Action

 Salem AM, Jackson IL, Gibbs A, Poirier Y, Newman D, Zodda A, Vujaskovic Z, Kaytor MD, Serebrenik AA, Gobburu J, Gopalakrishnan M. Interspecies Comparison and Radiation Effect on Pharmacokinetics of BIO 300, a Nanosuspension of Genistein, after Different R

Li Y, Girgis M, Jayatilake, Serebrenik AA, Cheema AK, Kaytor MD, Singh VK. Pharmacokinetic and metabolomic studies with a BIO 300 Oral Powder formulation in nonhuman primates. Scientific Reports, 2022;12(1):13475. PubMed PMID:35931769

Singh VK and Seed TM. BIO 300: a promising radiation countermeasure under advanced development for acute radiation syndrome and the delayed effects of acute radiation exposure. Expert Opinion on Investigational Drugs. 2020;29(5):429-441. PubMed PMID: 32450051.

Girgis M, Li Y, Ma J, Sanda M, Wise SY, Fatanmi OO, Kaytor MD, Cheema AK, Singh VK. Comparative proteomic analysis of serum from nonhuman primates administered BIO 300: a promising radiation countermeasure. Scientific Reports. 2020;10(1):19343. PubMed PMID: 33168863.

Cheema AK, Mehta KY, Santiago PT, Fatanmi OO, Kaytor MD, Singh VK. Pharmacokinetic and metabolomic studies with BIO 300, a nanosuspension of genistein, in a nonhuman primate model. International Journal of Molecular Sciences. 2019;20(5):1231. PubMed PMID: 30870965.

Warner M, Huang B, Gustafsson JA. Estrogen receptor beta as a pharmaceutical target. Trends in Pharmacological Sciences. 2017;38(1):92-99. PubMed PMID: 27979317.

Manas ES, Xu ZB, Unwalla RJ, Somers WS. Understanding the selectivity of genistein for human estrogen receptor-beta using X-ray crystallography and computational methods. Structure. 2004;12(12):2197-207. PubMed PMID: 15576033.