Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176), a specialist in urogenital cancer treatments, is preparing to unveil key findings from a global multicenter Phase III clinical study on its Cevira (APL-1702) at the Society of Gynecologic Oncology (SGO) annual meeting. The study focuses on the treatment of high-grade squamous intraepithelial lesions (HSIL) of the cervix with APL-1702, a groundbreaking cold light photodynamic drug-device combination product used as a non-surgical therapy.
The prospective, randomized, double-blind, placebo-controlled study aimed to assess the efficacy and safety of APL-1702 in treating HSIL, with the primary endpoint being the response rate at six months post-initial treatment. A response is defined as the normalization of cervical epithelial tissue pathology or a downgrade to low-grade squamous intraepithelial lesions (LSIL) of the cervix with clearance of HPV.
Between November 2020 and July 2022, 402 eligible subjects were enrolled in the study. Preliminary results indicate that the response rate in the APL-1702 group was significantly higher than that in the placebo group, at 89.4% versus 41.1% (P=0.0001). Moreover, the HPV clearance rate in the APL-1702 group showed a notable improvement over the control group in the modified intention-to-treat (mITT) population, with rates of 28.0% and 19.8%, respectively. The study also reported a low incidence of TRAE (treatment-related adverse events) and SAE (serious adverse events) in both groups, highlighting the treatment’s safety profile.- Flcube.com
