A Phase I trial combining IV fenretinide and IV safingol to target overproduction

PROJECT SUMMARY/ABSTRACT CerRx, Inc., Lubbock TX, a clinical stage anticancer drug development start-up company, requests critical funding via this SBIR Fast-Track Phase I/II application to support a highly novel, adult Phase I clinical trial of intravenous fenretinide + safingol, for which it licenses both formulation and drug combination IP rights. This trial will be subcontracted to the academic West Texas-based, South Plains Oncology Consortium (SPOC), based at the Texas Tech University Health SciencesCenter (TTUHSC). Fenretinide (4-HPR) is a p53- independent retinoid selectively cytotoxic to cancer cells via increase of reactive oxygen species and the de novo increase of native long chain D-erythro-dihydroceramides. Safingol is L-threo-dihydrosphingosine, an artificial stereochemical variant of sphinganine, the native precursor of dihydroceramides in mammalian cells. We have shown in human and canine cancer cell lines that safingol is incorporated into long-lived, L-threo- dihydroceramides. Our preclin