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