OSLO, Norway, Sept. 20, 2023 /PRNewswire/ --
The results of the study will be submitted to the Chinese National Medical Products Administration (NMPA) as part of a new drug application (NDA) in the coming months.
This study is a prospective, randomized, double-blind, placebo-controlled international multicenter Phase III clinical trial designed to evaluate the efficacy and safety of APL-1702 for the treatment of cervical HSIL. It is led by Academy Member Dr. Jinghe Lang from Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, and has enrolled 402 participants. The trial met its primary endpoint, together with a robust safety profile. Comprehensive data from this study will be presented at forthcoming academic conferences and published in scientific journals. Dr. Linda Wu, Chief Development Officer of Asieris Pharmaceuticals, said "This milestone marks a significant leap forward in the management of HSIL, with the potential to transform care in this domain. Moreover, tackling precancerous cervical conditions is pivotal for early prevention of cervical cancer and is an integral part of the three-tier cancer prevention system. Asieris Pharmaceuticals is committed to playing an active role in advancing China's Action Plan to Eliminate Cervical Cancer (2023-2030) and contributing to Healthy China 2030, aligning our efforts with the WHO's global strategy to accelerate the elimination of cervical cancer." "It is exciting to see that the Phase III clinical trial for Cevira has met its primary endpoint. There are many patients globally who can benefit from a non-surgical approach to treating high-grade squamous intraepithelial lesions (HSIL). Given the high unmet need and the importance of novel therapies to improve HSIL clinical outcomes, Photocure will continue to support Asieris, as our partner advances to the next stages of product development and regulatory approval," said Anders Neijber, Photocure's Chief Medical Officer. According to the Global Cancer Statistics 2020, there were 604,127 new cases of cervical cancer in women, with 341,831 deaths worldwide, ranking it as the fourth most prevalent malignancy among females.1 In China, cervical cancer ranks as the second most common malignancy among women. Read Asieris' full media release here: https://asieris.com/the-first-non-vaccine-investigational-product-for-cervical-hsil-has-achieved-its-primary-endpoint/ 1 Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209-49. 2 Expert Committee of Colposcopy and Cervical Pathology Branch (CSCCP) of Chinese Eugenics Association. Expert consensus on cervical cancer screening and abnormal management in China (II). Chinese Journal of Obstetrics and Gynecology, 2017, 18(3):286-288. (in Chinese) All trademarks mentioned in this release are protected by law and are registered trademarks of Photocure ASA.
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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), including all human papilloma virus (HPV) sub-types. 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 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:
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