IGF OT IGF RandD NANOEMULSION FORMULATION AND IND ENABLING STUDIES OF A NOVEL CENTER STEM CELL CYTOTOXIC AGENTPERIOD OF PERFORMANCE SEPTEMBER JULY

The proposed studies will create evaluate and validate the formulation dosing pharmacodynamics cytotoxicity efficacy and toxicology of a nanoemulsion of a novel cancer stem cell CSC cytotoxic drug DHA SBT In vitro and in vivo assays using FACS purified CSCs will be used to assess efficacy to kill differentiated tumor cells and CSCs NE DHA SBT will be administered intravenously i v to examine drug accumulation and biodistribution over time using validated analytical methods The goals of this proposal are to fully characterize a novel nanomedicine based dosage form of DHA SBT that addresses multi drug resistant gastrointesintal cancer GIC and other cancers and to prepare pre IND data required to move this therapy to the clinic Improving the delivery accumulation and pharmacokinetics of the CSC cytotoxic drug while limiting the systemic exposure will minimize cumulative dose dependent side effects and greatly increase efficacy For newly diagnosed GIC patients a majority of whom rapidly progress to a chemoresistant state due to CSCs the results of this investigation will offer a therapeutic solution that is urgently needed prior to exhausting the clinical options for highly aggressive forms of cancer The Pre IND studies outlined will be guided by clinical knowledge and experience as they advance to first in human clinical trials