In a stride forward for women’s health and cervical cancer prevention, Asieris Pharmaceuticals has declared the successful completion of its Phase III clinical trial for APL-1702 (Cevira), a non-surgical treatment aimed at cervical high-grade squamous intraepithelial lesions (HSIL). This significant milestone could shift the paradigm in treating this precancerous condition, offering a less invasive alternative to surgery, and may particularly benefit women of childbearing age.
The multinational, prospective, randomized, double-blind, placebo-controlled Phase III clinical trial was designed to evaluate the efficacy and safety of APL-1702 for the treatment of cervical HSIL. Orchestrated under the expertise of Dr. Jinghe Lang from Peking Union Medical College Hospital, the study enrolled 402 participants and met its primary endpoint, demonstrating robust safety and efficacy data.
“Comprehensive data from this study will be presented at upcoming academic conferences and published in scientific journals,” the company stated.
According to Global Cancer Statistics 2020, cervical cancer accounted for 604,127 new cases and 341,831 deaths worldwide, making it the fourth most common cancer among women. In China, it ranks as the second most common cancer among women. The leading cause of this malignancy is persistent HPV infection, which can cause precancerous cervical lesions. 20% of HSIL cases could advance to invasive cervical cancer within a decade, underscoring the importance of early and effective treatment.
Traditional treatments for cervical HSIL are often surgical and can result in complications such as cervical bleeding, infections, and cervical insufficiency. This latter condition could lead to reproductive issues, including premature delivery and miscarriage. Until now, there had been no non-vaccine, clinically verified treatment for precancerous cervical lesions.
APL-1702 (Cevira) is designed to fill this treatment gap as a non-invasive, photodynamic drug-device combination product. The procedure does not disrupt daily life and aims to spare patients from the often painful side effects associated with surgical procedures, especially focusing on preserving the fertility of women of child-bearing age.
Dr. Linda Wu, Chief Development Officer of Asieris Pharmaceuticals, emphasized, “This milestone marks a significant leap forward in the management of HSIL, with the potential to transform care in this domain.”