Theragnostic Technologies Inc. — Department of Health and Human Services SBIR Phase II: 300

Description

Abstract This SBIR phaseproject focuses on preclinical investigational new drugINDenabling studies of a novel high performance carbon nanostructure based X ray computer tomographyCTcontrast agentCAto be used to diagnose and monitor patients with renal failure or at risk of contrast induced nephropathyCINRoutine contrast enhanced CT provides crucial information about diseases and injuriesHowevercontrast induced nephropathyCINwhich may result from this procedureremains a leading cause of hospital acquired Acute Kidney InjuryAKIAboutmillion US residents suffer from acute kidney diseaseand approximatelymillion people are treated for mild to severe chronic kidney disease each yearMany diseases or conditions can lead to acute kidney injury and or chronic kidney diseaseAdditionallynon invasive imaging of kidney or other disease pathologiese gcancerfor patients with renal failureespecially at advanced stagesstill remains significant major challenge in clinical settingsWe have developed a novel nanoparticle based X ray CT CA called GNP I for imaging and monitoring in patients with renal failure or at risk of CINGNP I is comprised of graphenesingle sheet of graphitenanoparticles called graphene oxide nanoplateletsGNPfunctionalized with iodineiodine per GNP nanoparticleOur synthesis procedure leads to entrapment and covalently functionalization of iodine to the inner graphene sheet layersSubsequent functionalization with dextran imparts water dispersibility to the hydrophobic graphene particlesOur in vitro and in vivo studies indicate that equivalent CT performance can be achieved at substantially lowerthree orders lowerdosages than currently CAsThese resultstaken together with our in vivo small animal safety study in a contrast induced acute kidney injuryCI AKIrat modeli eno nephrotoxicity at diagnostic dosesand increased in vivo circulation time suggest exciting possibilities for its use as an organkidneyspecific CA and extended residence intravascular blood pool agentDuring phasethe overall objective will conduct key preclinical safety and efficacy studies towards investigational new drugINDapprovalAdditionallythe GNP I test article used in these studies will be synthesized and scaled up using a protocol that will eventually be used for the final clinical materialthereforewill be representative of the drug substance to be used in the clinical setting Project Narrative Routine X ray contrast enhanced Computer TomographyCTscan is essential for preventative screening and detecting diseased pathologieshowever presently available contrast agents are contraindicated in patients with renal insufficiencydiabetesheart failure and thyroid dysfunctionthese subjects being at risk for contrast induced nephropathyThere is an urgent requirement for safe and efficacious CT contrast agents to address this unmet clinical needOur proposed technology is a novel nanoparticlebased CT contrast agent for imaging and monitoring of vital organs in this high risk patient group