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. Although radiosensitization is integral to the treatment of many types of human cancers, the drugs currently available are also cytotoxic, and there is no drug with FDA approval for the indication of radiosensitization. IPdR represents a potential first-in-class non-cytotoxic radiation sensitizer to biologically enhance radiation therapy effects on cancers. In the proposed Phase II application, the Phase I clinical trial will be performed to determine safety and feasibility. This will allow Shuttle Pharmaceuticals to advance its proposed commercialization plan and to raise capital for efficacy clinical trials leading to FDA approval.