Study of the Effects of Brilacidin Oral Rinse on Radiation-induced Oral Mucositis in Patients With Head and Neck Cancer

Exclusion Criteria

• •1. Has tumor(s) of the lips, sinuses, salivary glands, nasopharynx, glottic larynx, subglottic larynx or unknown primary tumor
• •2. Has metastatic disease (M1) Stage IV C
• •3. Has had prior radiation to the head and neck
• •4. Plan to be treated with cetuximab (Erbitux®)
• •5. Planned use of cisplatin as induction chemotherapy.
• •6. Has a history of other malignant tumors within the last 5 years, except non melanoma skin cancer or in situ cervical carcinoma curatively excised
• •7. Has had a major surgical procedure, other than for HNC, or significant traumatic injury within 4 weeks prior to the initiation of RT; anticipation of need for major surgical procedure during the course of the study
• •8. Has incompletely healed sites of dental extractions
• •9. Has an 12-lead ECG obtained at screening visit which shows medically significant abnormality(ies) (e.g. left bundle branch block, frequent premature ventricular contractions, QTc interval prolongation \> 450 msec for males and \> 470 msec for females)
• •10. Has untreated hypertension or has hypertension under treatment that meets protocol definitions.
• •11. Has active infectious disease undergoing systemic treatment excluding oral candidiasis
• •12. Has oral mucositis (of any severity) prior to initiation of radiation therapy
• •13. Has a diagnosis of an immunosuppressive illness or a condition requiring chronic immunosuppression
• •14. Has known seropositivity for HIV or hepatitis C antibody, or known to be hepatitis B surface antigen positive (testing for these serologic markers is not required for enrollment in this protocol)
• •15. Use of any investigational agent within 30 days of randomization
• •16. Is pregnant or breastfeeding
• •17. Has known allergies or intolerance to brilacidin, cisplatin or carboplatin
• •18. Has inability to give informed consent or comply with study requirements
• •19. Has any other condition or prior therapy that in the opinion of the Investigator would make the patient unsuitable for the study and/or unable to comply with requirements for follow-up visits.
• •20. Is unwilling or unable to agree to swish and spit the study oral rinse three times per day during the study period