A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Assess the Safety and Efficacy of SC-07 for the Delay to Onset of Severe Oral Mucositis in Subjects Receiving Chemoradiation Therapy for the Treatment of Cancers of the Head and Neck.

Inclusion Criteria:

- Subject must have a body weight less than 150 kg at screening

- Have recently-diagnosed, pathologically-confirmed squamous cell carcinoma of the oral
cavity, oropharynx, hypopharynx or larynx that will be treated with chemoradiation
therapy as first line treatment(postoperative patients are eligible, if surgery is <
6 weeks prior to initiation of radiotherapy.

- Plan to receive a continuous course of conventional external beam irradiation

- Plan to receive a standard cisplatin chemotherapy regimen

Exclusion Criteria:

- Pregnant or breastfeeding

- Have head and neck tumors of the lips, sinuses, salivary glands or unknown primary
tumor

- Prior radiation to the head and neck

- Have a plan to receive cetuximab (Erbitux) in conjunction with chemotherapy

- Had curative surgery more than 6 weeks prior to the initiation of radiotherapy

- Have current oral mucositis

- Presence of active infectious disease excluding oral candidiasis

- Chronic immunosuppression

- Seropositive for HIV or hepatitis B surface antigen or C antibody

- Used an investigational agent within 30 days of randomization

- Have a known sensitivity to any investigational agent