OSLO, Norway, Sept. 17, 2024 /PRNewswire/ -- Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE: 688176) has communicated today that international multicenter Phase III clinical trial data for its non-surgical treatment for cervical HSIL (High-Grade Squamous Intraepithelial Lesion) product candidate Cevira® (APL-1702) have been accepted for oral presentation by the International Photodynamic Therapy & Photodiagnosis Update Conference in Germany on September 17, 2024, focusing on the efficacy data related to the regression of the histological grade of cervical precancerous lesions.
The Phase III trial is a prospective, randomized, double blind, placebo controlled, multi-center clinical study, which has reached its primary efficacy endpoint and exhibited good safety. Additionally, the study found that at 6 months after the first treatment, the regression rate (RR) in the APL-1702 group was significantly higher than that in the placebo group (47.0% vs. 29.5%, p < 0.01). Subgroup analysis data also showed that in all HPV-negative, HPV16-positive, and HPV18/others-positive subgroups, the APL-1702 group demonstrated favorable rates of histological regression comparing to placebo (64.7% vs. 25.0%, 37% vs. 25.4%, 60.0% vs. 36%). At 6 months after first treatment, the improvement rate for the two groups were 54% and 36%, respectively (p < 0.01). Among them, 38% of the subjects had cervical tissue restored to normal tissue at 6 months in the APL-1702 group, while only 19% had restoration to normal tissue in the placebo group. In the APL-1702 group, 79.1% of subjects had no disease progression, compared to 67.4% in the placebo group (p = 0.0171).
Read Asieris' full media release here: https://asieris.com/asieris-unveils-results-for-the-first-time-at-2024-pdtpd-conference-the-efficacy-data-of-non-surgical-treatment-of-cervical-hsil-with-apl-1702-in-reducing-the-histological-grade-of-cervical-preca/
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About Cevira®
Cevira® (APL-1702) is a photodynamic drug-device combination product in development. Based on the principles of photodynamic therapy, the Cevira product aims to use a photosensitizer in combination with light activation to produce a therapeutic effect as a non-surgical treatment of high-grade squamous intraepithelial lesions (HSIL) in patients aged 18 years and above, excluding carcinoma in situ.
Photocure developed Cevira through Phase I and Phase II trials, and the global rights for development and commercialization were out-licensed to Asieris Meditech Co., Ltd in 2019. In November 2020 Asieris initiated the phase III clinical trial for APL-1702 (Cevira) which achieved its primary endpoint in September 2023, Clinical trial number: NCT04484415. The new drug application for APL-1702 was accepted by the National Medical Products Administration (NMPA) in May 2024.
About Photocure ASA
Photocure: The Bladder Cancer Company delivers transformative solutions to improve the lives of bladder cancer patients. Our unique technology, making cancer cells glow bright pink, has led to better health outcomes for patients worldwide. Photocure is headquartered in Oslo, Norway and listed on the Oslo Stock Exchange (OSE: PHO). For more information, please visit us at www.photocure.com
About Asieris
Asieris Pharmaceuticals(688176.SH), founded in March 2010, is a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases.
For further information, please contact:
Dan Schneider
President and CEO
Photocure ASA
Email: ds@photocure.com
Erik Dahl
CFO
Photocure ASA
Tel: +4745055000
Email: ed@photocure.com
David Moskowitz
Vice President, Investor Relations
Photocure ASA
Tel: +1 202 280 0888
Email: david.moskowitz@photocure.com
Media and IR enquiries:
Geir Bjørlo
Corporate Communications (Norway)
Tel: +47 91540000
Email: geir.bjorlo@corpcom.no
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