This SBIR Program is to complete the development of a novel metalloporphyrin antioxidant compound, BMX-001, 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.
