A first-in-human proof-of-concept trial of intravaginal artesunate to treat cervical intraepithelial neoplasia 2/3 (CIN2/3)
Gynecologic Oncology Feb 05, 2020
Trimble CL, Levinson K, Maldonado L, et al. - Researchers focused on the utility of self-administered artesunate vaginal inserts in biopsy-verified cervical intraepithelial neoplasia 2/3 (CIN2/3), with a focus on safety and efficacy of this treatment option in this first-in-human Phase I dose-escalation study, given artesunate is a WHO-approved compound for treatment of acute malaria and it also has cytotoxic influence on squamous cells transformed by HPV. At study weeks 0, 2, and 4, overall 28 patients were administered 1, 2, or 3 five-day treatment cycles, respectively, before a planned, standard-of-care resection at study week 15. Mild, and self-limited adverse events were documented. Overall 19/28 (67.9%) cases demonstrated histologic regression in the modified intention-to-treat analysis. Findings overall revealed the safety as well as good tolerability of self-administered vaginal artesunate inserts, at clinically effective doses to treat CIN2/3.
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