Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176), a specialist in urogenital cancer treatments, has announced that its Phase III clinical study for Cevira (APL-1702) in high-grade squamous intraepithelial lesions (HSIL) of the cervix has successfully reached its primary endpoint.
Study Design and Results
The global, multi-center Phase III study was designed as a prospective, randomized, double-blinded, placebo-controlled trial to assess the efficacy and safety of Cevira in treating cervical HSIL. A total of 402 subjects were enrolled in the study. Completed statistical analysis results indicate that the study has met its primary efficacy endpoint, with the product demonstrating good safety. Asieris anticipates initiating discussions with regulatory authorities regarding market filing in the near future.
Significance of Cevira’s Success
Cevira is a photodynamic device-drug combination therapy specifically for cervical HSIL. It is noteworthy that there is no non-vaccine product targeting cervical HSIL that has been confirmed to be efficacious through Phase III clinical trials and approved anywhere in the world. The success of Cevira’s Phase III study positions it as a potential breakthrough in the treatment of cervical HSIL.-Fineline Info & Tech
