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2024-03-18 10:05:58
Press Release - Oslo, Norway, March 18, 2024: Photocure ASA (OSE: PHO), the
Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE:
688176) has communicated today the Phase III clinical study results for its non
-surgical treatment candidate for cervical high-grade squamous intraepithelial
lesions (HSIL) Cevira[®] (APL-1702). The results were presented at two recent
medical congresses and demonstrated highly statistically significant efficacy
and a favorable safety profile for Cevira, with a significant clearance rate of
high-risk HPV16 and/or HPV18 compared to placebo (p=0.0001).
Key data from the international multicenter Phase III trial were presented for
the first time last week, in oral presentations at the 2024 European Research
Organization on Genital Infection and Neoplasia (EUROGIN) Congress, March 13-16
in Stockholm, Sweden, and at the 2024 SGO Annual Meeting on Women's Cancer of
the Society of Gynecologic Oncology, March 16-18 in San Diego, CA, USA.
· Cevira (APL-1702) is a pioneering photodynamic drug-device combination
product used as a non-invasive therapy for treating cervical high-grade squamous
intraepithelial lesions (HSIL). This study is a large 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 over 12 months. The primary endpoint of the study is the
proportion of responders at 6 months after the initial treatment.
· Between November 2020 and July 2022, 402 eligible patients from various
countries including China, Germany, and the Netherlands were randomized and
enrolled in this study. In terms of the primary efficacy endpoint, the response
rate in the APL-1702 group was significantly higher than that in the control
group, with an increase of 89.4% (41.1% vs. 21.7%, p = 0.0001), which is
considered a highly clinically relevant effect. Additionally, APL-1702 showed an
improved clearance rate of high-risk HPV16 and/or HPV18, with a 103.9% increase
in the APL-1702 group compared to the control group (31.4% vs. 15.4%).
· The incidence of treatment-emergent adverse events (TEAEs) was comparable
between the APL-1702 group and the control group, with the majority being mild
and self-resolving without requiring intervention. The occurrence rates of
treatment-related adverse events (TRAEs) and serious adverse events (SAEs) were
low in both groups.
· The current progress involves ongoing communication with regulatory
authorities in China and preparing for the submission of the new drug
application for APL-1702. Additionally, active efforts are being made to advance
development of the product outside of China.
"We are very pleased to see the strong results of this randomized controlled
Phase III clinical trial in which Cevira (APL-1702) demonstrated clear benefit
in patients with HSIL. Based on the results, treatment with Cevira has the
potential to fill an unmet clinical need as an alternative to conventional
surgical therapies for HSIL", said Anders Neijber, Photocure's Chief Medical
Officer. "At present, Photocure teams are supporting Asieris' to prepare the new
drug application (NDA) for Cevira (APL-1702) in China, with the goal of bringing
this innovative therapy to a larger number of patients as soon as possible."
According to the press release, the main cause of cervical cancer is persistent
infection with human papillomavirus (HPV), which leads to precancerous lesions
of the cervix. Approximately 25% of individuals with HSIL may progress to
invasive cervical cancer within 10 years. Read Asieris' full media release here:
https://asieris.com/breakthrough-in-treatment-of-cervical-high-grade-squamous
-intraepithelial-lesion-release-of-positive-results-from-multicenter-phase-iii
-global-clinical-study/
Cevira (APL-1702) has potential to become a breakthrough photodynamic drug
-device combination product that can offer patients the option of non-surgical
treatment of high-grade precancerous lesions of the cervix. Photocure developed
Cevira through Phase 1 and Phase 2 trials, and the global rights for development
and commercialization were out-licensed to Asieris Meditech Co., Ltd in 2019.
Asieris is a global biopharma company specializing in discovering, developing
and commercializing innovative drugs for the treatment of genitourinary tumors
and other related diseases.
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 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, www.hexvix.com, www.cysview.com
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