EN3285 for the Prevention or Delay of Oral Mucositis in Patients With Head and Neck Cancer

Significant Inclusion Criteria: * 18 years and older * newly diagnosed SCC of the oral cavity and/or oropharynx, and are intended for treatment with ChemoRT. * Have a clinical plan to receive a minimum of 60 Gy to the oral cavity and/or oropharynx * Chemotherapy: cisplatin * Have a WBC ≥3500 per cubic millimeter * Have a platelet count ≥100,000 per cubic millimeter * Have adequate renal function as determined by the principal investigator prior to enrollment * Are willing and able to undergo oral assessments * Have a Karnofsky Performance Status score ≥70 Significant Exclusion Criteria: * Have OM or other oral conditions at study entry * Plan to use Amifostine, Pilocarpine, Cevimeline or Bethanechol * Are using a pre-existing feeding tube for nutritional support at study entry * Plan to use any drug for the treatment or prevention of OM * Have had any prior radiotherapy to the head and neck * Have had prior chemotherapy within 6 months preceding enrollment * Plan to have concurrent chemotherapy, other than those regimens specified under inclusioncriteria * Have received other investigational drugs in the 30 days preceding initiation of study drug or during administration of study drug * Have medical conditions that require the use of chronic steroid therapy * Have the inability to undergo repeat treatments,