DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer

Inclusion Criteria: * Biopsy-proven squamous cell carcinoma of the oral cavity or oropharynx without distant organ metastases * Scheduled to receive cisplatin chemotherapy of 80-100 mg/m² * Scheduled to receive a continuous course of fractionated, conventional external beam with a cumulative radiation dose between 55 and 72 Gy at each site Exclusion Criteria: * Current mucositis * Current, clinically significant, active infection that in the opinion of the Investigator would make them an unfit participant in the trial * Planned to receive Erbitux™ (Cetuximab) or similar targeted therapy between Baseline and 6 weeks post-RT * Prior radiation to the head and neck * Chemotherapy treatment within the previous 12 months * Tumors of the lips, sinuses, salivary glands, nasopharynx, hypopharynx, or larynx * Evidence of significant renal, hepatic, hematologic, or immunologic disease determined by any one of the following: Estimated creatinine clearance \<30 mL/min; ALT or AST level greater than 10-fold the upper limit of normal or total bilirubin greater than 3-fold the upper limit of normal; Manifestations of end-stage liver disease, such as ascites or hepatic encephalopathy; Thrombocytopenia; or CD4+ T cell count below 200 cells per μL * Evidence of immediate life-threatening disease or a life expectancy of less than 3 months * Women who are pregnant or breast-feeding * Participation in any study involving administration of an investigational agent within 30 days of randomization into this study