Ongoing Clinical Trials

Clinical trials are currently underway for the treatment of three types of pre-cancerous lesions using a proprietary formulation of artesunate. Artesunate is a derivative of artemisinin. Its anti-malarial properties have been effective in treating millions of malaria patients, and now it has been formulated in proprietary compounds for topical delivery by Frantz Viral Therapeutics.

In these clinical trials topical artesunate is self-administered via vaginal inserts (similar to yeast infection treatment), anal suppositories, or as an ointment for pre-cancers of cervical, perianal and vulvar/vaginal tissues respectively. The results of the Phase I/IIA studies of artesunate for the treatment of CIN2/3, AIN2/3, and VIN2/3 were: published in Gynecologic Oncology (CIN); was a podium presentation at the American Society for Colon and Rectal Surgeons (ASCRS) 2022 Annual Scientific Meeting (AIN); and was a poster presentation at the 2023 International Papillomavirus Conference (VIN).

“The availability of a well-tolerated, non-surgical treatment option for persons with HPV-related precancer and persistent HPV infection holds tremendous potential for changing the landscape of care for these conditions, both in the US and globally.”
Dr. Sahasrabuddhe, Program Director, Breast and Gynecologic Cancer Research Group Division of Cancer Prevention, National Cancer Institute, National Institutes of Health

For detailed information about these clinical trials, visit clinicaltrials.gov. In the Find a study section, select All Studies. Under Conditions and disease, enter Intraepithelial neoplasia. Under Other terms, enter artesunate. Under Country, enter United States.

Cervical Intraepithelial Neoplasia (CIN2/3) Phase IIB Clinical Trial

Status: RECRUITING

The University of Texas MD Anderson Cancer Center/Harris Health System Lyndon B. Johnson Hospital, Houston, Texas
Cleveland Clinic Main Campus/Cleveland Clinic Hillcrest Hospital/Cleveland Clinic Fairview Hospital, Cleveland, Ohio
Morehouse School of Medicine/Grady Health System, Atlanta, Georgia
University of Michigan, Ann Arbor, Michigan

Primary Objective:

To determine the effectiveness of three 5-day cycles of artesunate vaginal inserts (vaginal suppositories) in adult females with high grade cervical dysplasia caused by HPV

Secondary Objectives:

To evaluate the safety of artesunate vaginal inserts (vaginal suppositories) for the treatment of high-grade cervical dysplasia (CIN2/3)
To evaluate clearance of HPV after three 5-day cycles of artesunate
To evaluate the clearance of HPV after three 5-day cycles of artesunate and the LEEP procedure

Eligible participants in this study are randomized 2:1 to receive either artesunate or placebo vaginal inserts for the treatment of CIN2/3. Both groups receive three 5-day cycles of the respective insert, at weeks 0, 2, and 4. Dosing visits can be done as telehealth visits (medication is mailed to the patient’s home). Participants are followed after receiving artesunate at weeks 6, 17, and 40. All participants undergo a LEEP procedure at week 17.

Eligibility:

Adult females age 25 years and older
Capable of informed consent
Any HPV genotype detectable by DNA test/HPV genotyping
Biopsy diagnosis of either CIN2, CIN3 or CIN2/3 after colposcopy
Women of childbearing potential must agree to use birth control through week 17 of the study
Weigh at least 110 pounds

Exclusions:

Pregnant and nursing women
Active autoimmune disease
Taking immunosuppressive medication
Immunocompromised individuals
HIV diagnosis
Evidence of concurrent cervical cancer or adenocarcinoma in situ
Concurrent other malignancy, except for non-melanoma skin lesions

Locations:
The University of Texas MD Anderson Cancer Center/Harris System Lyndon B. Johnson Hospital, Houston, Texas

Principal Investigator: Andrea Milbourne, MD
Co-Investigator: Kathleen Schmeler, MD

Contacts:

Name: Jessica Gallegos
Phone Number: 713-563-4580
Email Address: jrgalleg@mdanderson.org

Name: Cindy Melendez
Phone Number: 713-563-4582
Email Address: cvmelend@mdanderson.org

Cleveland Clinic Main Campus/Cleveland Clinic Hillcrest Hospital/Cleveland Clinic Fairview Hospital, Cleveland, Ohio

Principal Investigator: Chad Michener, MD

Contact:

Name: Donna White
Phone Number: 216-445-8090
Email Address: whited11@ccf.org

Name: Megan Park
Phone Number: 216-445-8090
Email Address: mailto:parkm2@ccf.org

University of Michigan, Ann Arbor, Michigan

Principal Investigator: Diane Harper, MD

Contacts:

Name: Emma Alman, MPH
Phone Number: 734-780-6984
Email Address: almane@med.umich.edu

Name: Elizabeth Haro
Phone Number: 734-277-9808
Email Address: FAMMMED-MISSH@med.umich.edu

Vulvar High-Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3) Phase IIB Clinical Trial

Status: OPENING SOON at Cleveland Clinic, MD Anderson Cancer Center and Harris Health Systems / LBJ Hospital

Anal High Grade Squamous Intraepithelial Lesions (Anal HSIL) in HIV-negative individuals Phase IIB Clinical Trial

Status: RECRUITING

Anal Dysplasia Clinic Midwest, Chicago, Illinois
Laser Surgery Care, New York, New York

Primary Objective:
To evaluate the effectiveness of four 5-day cycles of artesunate suppositories in the treatment of HIV-negative individuals who have anal intraepithelial squamous lesions (anal HSIL)

Secondary Objectives:
Efficacy:

To evaluate clearance of HPV after four 5-day cycles of artesunate suppositories over the study window (42 weeks)
To evaluate the effectiveness of artesunate suppositories to treat intra-anal HSIL, documented after 18 weeks but over the study window (30 weeks).
To evaluate the effectiveness of artesunate suppositories in treating peri-anal HSIL, over the course of the study (42 weeks).
To evaluate persistence of the artesunate treatment throughout the study window (42 weeks)

Safety:
To evaluate the safety of artesunate suppositories for the treatment of intra-anal HSIL.

This is a Phase II double blind, placebo-controlled, randomized study of artesunate suppositories for the treatment of HIV-negative men and women who have intra-anal high grade squamous intraepithelial lesions (anal HSIL). Patients whose lesions shrink 50% or more in size by the week 18 visit will have the option to be followed at week 30 and 42. Those whose lesions regress completely will be able to avoid the surgical/ablation.

Eligibility:

Adult men and women age 18 years and older
Capable of informed consent
Biopsy-confirmed intra-anal high-grade dysplasia (AIN 2, AIN 3, anal HSIL) by HRA. Patients must have residual anal HSIL lesion(s) after diagnostic biopsies, as documented by HRA.
Women of childbearing potential agree to use birth control through the duration of the study
Weigh at least 110 pounds
Organ function laboratory results within normal limits
Electrocardiogram (ECG) with no clinically significant findings

Exclusion Criteria:

Pregnant and nursing women
Diagnosis of low-grade anal dysplasia (AIN 1, LSIL), without a diagnosis of anal HSIL, by HRA
Concurrent anal, vulvar, cervical, or penile cancer
HIV positive
Currently receiving systemic chemotherapy or radiation therapy for another cancer.
Patients who are on medical treatment with immunosuppressants or steroids
Use of strong UGT inhibitors
Use of imiquimod or 5—fluorouracil (5-FU) for the duration of the study

Locations:

Anal Dysplasia Clinic MidWest, Chicago, Illinois

Principal Investigator: Gary Bucher, MD

Contact:

Name: Gary Bucher, MD
Phone Number: 312-623-2625
Email Address: garybuchermd@adcmidwest.com

Laser Surgery Care, New York, New York

Principal Investigators: Stephen Goldstone, MD
Joseph Terlizzi, MD

Contact:

Name: Janet Nguyen
Phone Number: 212-242-6500
Email Address: jnguyen@lasersurgerycare.com