Earnings Release • Sep 20, 2023
Earnings Release
Open in ViewerOpens in native device viewer
Photocure Partner Asieris announces that the First Non-Vaccine Investigational Product for Cervical HSIL has Achieved Its Primary Endpoint
Press Release - Oslo, Norway, September 20, 2023: Photocure ASA (OSE: PHO), the
Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE:
688176) has communicated today that the multinational Cevira[®] Phase III
clinical trial has been completed and successfully met its primary endpoint.
Cevira (APL-1702) is a photodynamic drug-device combination product in
development for the non-surgical treatment of high-grade squamous
intraepithelial lesions (HSIL), licensed to Asieris by Photocure.
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.
The primary cause of cervical cancer is persistent HPV infection, leading to
precancerous cervical lesions. Alarmingly, approximately 20 percent of
individuals with HSIL may progress to invasive cervical cancer within a span of
10 years.[2 ]According to Frost & Sullivan, the number of HSIL patients is
projected to reach 16.6 million globally and 2.2 million in China by 2030.
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)
Note to editors:
All trademarks mentioned in this release are protected by law and are registered
trademarks of Photocure ASA.
This press release may contain product details and information which are not
valid, or a product is not accessible, in your country. Please be aware that
Photocure does not take any responsibility for accessing such information which
may not comply with any legal process, regulation, registration or usage in the
country of your origin.
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), including all human papilloma virus (HPV) sub
-types.
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), Clinical trial number:
NCT04484415 (https://classic.clinicaltrials.gov/ct2/show/NCT04484415).
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: [email protected]
Erik Dahl
CFO
Photocure ASA
Tel: +4745055000
Email: [email protected]
David Moskowitz
Vice President, Investor Relations
Photocure ASA
Tel: +1 202 280 0888
Email: [email protected]
Media and IR enquiries:
Geir Bjørlo
Corporate Communications (Norway)
Tel: +47 91540000
Email: [email protected]
Building tools?
Free accounts include 100 API calls/year for testing.
Have a question? We'll get back to you promptly.