THERASOURCE, LLC — Department of Health and Human Services SBIR Phase II: NIAID

Description

DESCRIPTIONprovided by applicantThis SBIR Phase II proposal is intended to further develop human ghrelin as a radiation medical countermeasureMCMto be approved by the FDA in the futureThe risks of nuclear terrorism and nuclear power plant leaks still remain highboth of which can cause acute radiation injury on a large scaleCurrentlythere are limited drugs available to treat acute radiation syndromeARSHuman ghrelin is aamino acid peptide hormone with broad effects on various body systemsincluding the endocrinegastrointestinalGIcardiovascularand immune systemsIn our completed SBIR Phase I projectwe have exposed rats and mice to total body irradiationTBIand demonstrated that subcutaneous administration of human ghrelin fordaysstarting ath post TBIsignificantly increased their survival rates and reduced their body weight lossWe further demonstratedin the ratthat treatment with human ghrelin improved intestinal integrity and reduced gut apoptosis and permeabilityHuman ghrelin can be synthesized in large quantity for mass emergency needsMoreoverhuman ghrelin has been tested in several clinical trials for other disease indications with an excellent safety profileBased on our positive Phase I resultswe hypothesize that human ghrelin can be developed as an effective post exposure mitigator for acute radiation injuryIn this proposalwe will use the mouse model of radiation injury to identiy the dose modification factorDMFof human ghrelin to treat GI ARS and hematopoietic ARSHARSWe will also examine human ghrelin s effect to attenuate hematopoietic and GI damagesIn additionwe will conduct an exploratory study in non human primatesNHPto evaluate the effect of human ghrelin treatment on the GI and hematology response to radiation exposureThese proposed studies should provide crucial information on the efficacy of human ghrelin as a novel radiation MCM primarily targeting GI ARSOur ultimate goal is to obtain the FDA approval to use human ghrelin as a safe and effective treatment for people with acute radiation injury after a radiation emergency