A Proof of Concept Trial Investigating Safety and Efficacy of APG-157 in Oral Dysplasia

Exclusion Criteria

• •1. Pregnant women.
• •2. Subjects who have had surgery of the oral cavity, teeth, or gums within the previous 8 weeks excluding biopsies and tooth extractions.
• •3. Subjects who have had a fracture of the mandible or maxilla within the previous 8 weeks.
• •4. Inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness).
• •5. History of prior head and neck squamous cell carcinomas (HNSCC) unless curatively treated 1 year or more prior.
• •6. Use of chemotherapy and/or radiation for any malignancy (excluding nonmelanoma skin cancer and cancer confined to organs with removal as only treatment) in the past 2 years.
• •7. Subjects with other related diseases or the oral cavity or oropharynx, as determined to be significant by the PI.
• •8. History of allergic reactions attributed to compounds of similar chemical composition to Curcumin (turmeric).
• •10. Severe thrombocytopenia increasing the risk of biopsy.
• •11. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.