Intra-Anally Administered Artesunate in Patients With High-Grade Anal Intraepithelial Neoplasia (AIN 2/3)

Patients diagnosed with AIN 2/3 will be enrolled sequentially in treatment cohorts receiving
different doses of Artesunate suppositories administered trans-anally. Doses of escalation
will be 200 mg, 400 mg, and 600 mg. Treatment cohorts will consist of 2 or 3 cycles at each
dose level. Suppositories will be administered daily for 5 days. Five days constitutes 1
cycle. Up to 3 cycles will be administered at Weeks 0, 2, and 4.

Inclusion Criteria:

- Age ≥ 18 years

- Biopsy-confirmed high-grade anal dysplasia (AIN 2, AIN 3, HSIL) by high resolution
anoscopy (HRA)

- Female of childbearing potential: negative urine pregnancy test

- Able to provide informed consent

- Patients who have the ability to collaborate with planned follow-up (transportation,
compliance history, etc.).

- Weight ≥50 kg.

Exclusion Criteria:

- Diagnosis of low-grade anal dysplasia (AIN 1, LSIL) by high resolution anoscopy

- Known anal, vulvar, cervical, or penile cancer

- CD4 count < 200 at the time of consideration for entry into this study

- Unable to provide informed consent

- Currently receiving systemic chemotherapy or radiation therapy for another cancer.

- Patients who are on medical treatment with systemic immunosuppressants or steroids
(e.g., active autoimmune disease)

- Extensive anal condyloma precludes the ability for the clinician to visualize HSIL
during HRA