SGX942 to Decrease Oral Mucositis After Chemoradiation for Head and Neck Cancer

DESCRIPTION (provided by applicant): Oral mucositis has a significant impact on patient quality of life and outcomes during cancer therapy as well as having a significant pharmacoeconomic cost. There are no currently approved drugs to treat oral mucositisin patients with non-hematological malignancies, including head and neck cancer (HNC). Soligenix is developing a new compound, SGX942, a modulator of the innate defense system, which binds to the p62 protein. p62 is a key adaptor protein that functions downstream of key sensing receptors of the innate defense system. Preclinical studies with SGX942 revealed a significant reduction in both duration and peak intensity of oral mucositis in both a fractionated radiation-induced hamster model of oral mucositisand a chemotherapy- induced mouse model of oral (tongue) mucositis: there was ~50% reduction in the duration of severe mucositis. Efficacy was dose responsive and optimal at 25 mg/kg dosed every third day during fractionated radiation therapy. Based o