Positive Cevira Phase III Results Presented at 2024 Medical Congresses

In a significant advancement for cervical cancer treatment, Photocure ASA, a company renowned for its contributions to bladder cancer solutions, has announced the positive outcomes of a Phase III clinical trial for a novel non-surgical treatment for high-grade squamous intraepithelial lesions (HSIL), a precursor to cervical cancer. The treatment, known as Cevira (APL-1702), was developed in partnership with Asieris Pharmaceuticals and was showcased at the 2024 EUROGIN Congress and the SGO Annual Meeting on Women's Cancer.

Cevira represents an innovative photodynamic drug-device combination, offering a non-invasive approach to treating HSIL. The Phase III trial, a substantial international study involving 402 patients from China, Germany, and the Netherlands, was conducted between November 2020 and July 2022. The trial was designed as a prospective, randomized, double-blind, placebo-controlled study with the primary goal of assessing the response rate at six months post-treatment.

The results were notably in favor of Cevira, with an 89.4% increased response rate compared to the placebo group (41.1% vs. 21.7%, with a p-value of 0.0001), marking a significant clinical benefit. Furthermore, Cevira showed an impressive 103.9% improvement in clearing high-risk HPV16 and/or HPV18 infections compared to the control group.

Safety was also a key focus of the study, and Cevira demonstrated a comparable incidence of treatment-emergent adverse events (TEAEs) to the control group, with most events being mild and self-limiting. The rates of treatment-related adverse events (TRAEs) and serious adverse events (SAEs) were low across both groups.

Asieris Pharmaceuticals is currently in discussions with Chinese regulatory authorities and is preparing to submit a new drug application for APL-1702. There are also ongoing efforts to expand the product's development beyond China.

Anders Neijber, Photocure's Chief Medical Officer, expressed enthusiasm for the trial's results, highlighting the potential of Cevira to meet an unmet clinical need by providing an alternative to traditional surgical treatments for HSIL. Photocure is actively supporting Asieris in the preparation of the new drug application in China, aiming to make this innovative therapy available to a broader patient population.

The primary cause of cervical cancer is identified as persistent infection with human papillomavirus (HPV), leading to precancerous cervical lesions. It is estimated that about 25% of individuals with HSIL could develop invasive cervical cancer within a decade.

Cevira, developed by Photocure through Phase 1 and Phase 2 trials, has the potential to revolutionize cervical precancer treatment by offering a non-surgical option. The global development and commercialization rights were licensed to Asieris Meditech Co., Ltd in 2019. Asieris is a global biopharmaceutical company that specializes in innovative drug discovery, development, and commercialization for genitourinary tumors and related diseases.

Photocure ASA, headquartered in Oslo, Norway, is listed on the Oslo Stock Exchange and is dedicated to improving the lives of bladder cancer patients through unique technologies that enhance health outcomes. The company's commitment to innovation and patient care is evident in its pursuit of transformative solutions in oncology.