Study on the Safety and Effectiveness of APG-157 for Oral Dysplasia

Inclusion Criteria

• Adults over 18 years old with moderate to severe oral dysplasia or carcinoma in situ, confirmed by a biopsy, and a visible lesion in the mouth or throat.
• The lesion must be at least 8 x 3 mm in size before the initial biopsy.
• Willing to provide blood samples, oral rinses, and tissue from biopsies for the study.
• Have certain blood counts and liver function within normal limits, unless deemed not significant by the study doctor.
• Agree to use effective birth control during the study if applicable.
• Able to take medication by mouth.
• Understand and agree to sign a consent form to participate in the study.

Exclusion Criteria

• Pregnant women.
• Recent surgery in the mouth, teeth, or gums within the last 8 weeks, except for biopsies and tooth extractions.
• Recent jaw fractures within the last 8 weeks.
• Difficulty completing forms due to mental or language issues.
• History of head and neck cancer unless treated and cured over a year ago.
• Recent chemotherapy or radiation for any cancer in the last 2 years, except for certain skin cancers.
• Other significant oral or throat diseases as determined by the study doctor.
• Allergic reactions to turmeric or similar compounds.
• Active or chronic liver disease, hepatitis, or liver conditions, unless deemed not significant by the study doctor.
• Low platelet count that increases biopsy risk.
• Uncontrolled illnesses like infections, heart failure, unstable heart conditions, or psychiatric issues that could affect study participation.