Cobiprostone for the Prevention of Oral Mucositis in Subjects With Head and Neck Cancer

Inclusion Criteria:

- Recently-diagnosed (within the last 6 months), histologically-documented,
non-metastatic squamous cell carcinoma of the oral cavity and/or oropharynx amenable
to radiotherapy with concurrent chemotherapy as the definitive treatment modality.

- Clinical treatment plan calls for a minimum of 50 Gy cumulative radiation dose
administered via continuous course of external beam irradiation to the oral cavity
and/or oropharynx via intensity-modulated radiation therapy [IMRT] and/or
image-guided radiation therapy [IGRT], combined with conventional or
weekly/tri-weekly cisplatin or carboplatin chemotherapy regimen.

Exclusion Criteria:

- Subject has received prior radiation to the head and neck region (+/- chemotherapy).

- Subject has had any other prior invasive malignancy, unless disease-free for a
minimum of 3 years.

- Subject has metastatic disease (M1) Stage IV-C.

- Subject has a presence of mucosal ulceration or oral mucositis at screening or
develops this prior to randomization, and/or has unhealed wounds remaining from
surgical resection and/or excisional biopsy procedure.

- Subject is using a pre-existing feeding tube for nutritional support at study entry.