Clinical Development of IPdR for Radiosensitization

Shuttle Pharmaceuticals, Llc, Rockville MD

Investigators

Abstract

The objective of this fast-track SBIR Application is to advance commercialization efforts for IPdR (5-iodo-2pyrimidinone-2'-deoxyribose), a prod rug of the radiosensitizer IUdR (5-iodo-2'-deoxyuridine). In the Phase I SBIR, we will determine the scientific merit, feasibility and potential for commercialization of oral lPdR as a radiation sensitizer for use in cancer treatment. Administrative tasks will be completed to enable an IND for Shuttle Pharmaceuticals, LLC; formulation of GMP manufactured IPdR into 300 mg capsules; submission of a letter of intent (LOI) to CTEP; protocol preparation and IRB approval for the proposed Phase I clinical trial and establishment of companion diagnostics for analyzing clinical specimens from Phase I patients. The tasks detailed for the Phase I effort are intended to facilitate an IND for IPdR for Shuttle Pharmaceuticals.