Development of BIO as a MCM for lethal radiation pneumonitis fibrosis

Project Summary A significant need exists for effective medical countermeasures for radiation induced pneumonitis and pulmonary fibrosis associated with the delayed effects of acute radiation exposure Of great importance are countermeasures that can be distributed for use without medical supervision making orally effective countermeasures of high interest and importance To address this unmet need Humanetics Corporation is developing BIO Oral Suspension active ingredient genistein to treat the delayed effects of acute radiation exposure DEARE in the lung Genistein a non specific tyrosine kinase inhibitor has a strong history of safety and has substantial radioprotective effects linked to its strong antioxidant capacity anti inflammatory properties and its effects on cell cycle division In preclinical studies summarized in this proposal BIO has been shown to significantly improve survival mitigate lung tissue injury and improve pulmonary function following whole thoracic lung irradiation The aim of this proposal is to determine the optimum therapeutic dosing regimen of BIO to reduce lung damage and maximize the likelihood for survival following acute radiation exposure to the thoracic region Models in which the dose response and timecourse of radiation induced pulmonary damage are well defined will be used in the proposed studies Studies are also proposed to further understand the effect that total or partial body irradiation has on BIO s pharmacokinetic properties The overall goal of the proposed studies is to advance the development of BIO as a medical countermeasure towards FDA approval The proposed work builds on the Randamp D experience of Humanetics Corporation toward the development of BIO as a medical countermeasure for acute radiation exposure The main emphasis of future development will be to move BIO development into large animal efficacy testing to determine if the positive efficacy data observed in the rodent model translates to a larger animal Continued development of BIO will undoubtedly expand the scientific knowledge base and support the continued evaluation and development of agents to prevent and or treat the acute and chronic effects of radiation exposure Moreover with BIO s advanced development as a medical radiation countermeasure and as an adjunct to cancer radiotherapy it presents an opportunity for an accelerated development course through pivotal efficacy trials and to licensure Project Narrative Short term exposure to a high dose of total or partial body irradiation such as from a nuclear accident or act of terrorism has both acute and delayed effects on bodily organs Humanetics is developing a treatment for the delayed effects of acute radiation exposure to the lung This drug BIO is a liquid formulation that is shelf stable safe and can be administered without the need for medical supervision In this proposal Humanetics is working with experts at the University of Maryland School of Medicine to determine the most effective treatment course for BIO The goal is to continue BIO s development toward FDA approval as a drug to mitigate radiation induced lung damage