IGF OT IGF RADIOPROTECTOR FOR HEAD AND NECK CANCER PERIOD OF PERFORMANCE

This SBIR Program is to complete the development of a novel metalloporphyrin antioxidant compound BMX to be used as a radioprotector in the treatment of patients with head and neck cancer undergoing radiation therapy This drug product has been produced to GMP quality safety toxicology completed in one species and a high degree of efficacy demonstrated for both protecting against radiation induced side effects and inhibiting cancer growth in head and neck cancer Under Phase I in this SBIR studies in mice will optimize dose response for its function as a radio protectant and confirm that it does not interfere with the effect of radiation therapy and cisplatin on tumor killing Safety toxicology studies will confirm the absence of neuropharmacologic adverse effects and that the drug is not mutagenic Phase II studies will complete safety toxicology required for an IND and support both Phase I and Phase II proof of concept clinical trials