Regulatory Filings • Sep 30, 2024
Regulatory Filings
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Photocure Partner Asieris Unveils Cevira (APL-1702) Phase III Subgroup Analysis by Age Groups at the 2024 CSCO Annual Meeting
Press Release - Oslo, Norway, September 30, 2024: Photocure ASA (OSE: PHO), the
Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE:
688176) communicated that international multicenter Phase III clinical study
data for its non-surgical treatment candidate Cevira[®] (APL-1702) for cervical
High-Grade Squamous Intraepithelial Lesion (HSIL) has been published by the
27[th] Chinese Society of Clinical Oncology (CSCO) Annual Meeting as a poster,
focusing on the analysis of different age subgroups regarding the six-month
pathological regression rate and HPV clearance rate.
This Phase III clinical trial is a prospective, randomized, double blind,
placebo controlled, multi-center clinical study, which has reached its primary
efficacy endpoint and exhibited good safety.
Furthermore, the study results included the pathological regression rate
(defined as the proportion of subjects with a pathological regression to CIN1 or
normal tissue) at the 6[th] month across different age subgroups. Both the "?20
and <30 years" subgroup and the "?30 and <40 years" subgroup showed an increase
of 15% to 20% in the pathological regression rate in the APL-1702 group compared
to the placebo control group. No cervical cancer events were reported,
suggesting a significant therapeutic potential of APL-1702 in the HSIL
population aged 20 to 40 years.
Regarding HPV clearance rate, in the "?20 and <30 years" age group, the APL-1702
group showed enhancements in the overall HPV clearance rate, HPV16-positive
clearance rate, and HPV16/18-positive clearance rate compared to the placebo
control group. The patients' number in the "<20 years" and "?40 years" age
groups were limited, thus the results in these age groups require a validation
study with a larger sample size. Overall, APL-1702 not only facilitates the
regression from HSIL to LSIL but also demonstrates the ability to induce
clearance of high-risk HPV infections.
Read Asieris' full media release here: https://asieris.com/asieris-unveils
-results-for-the-first-time-at-2024-csco-conference-the-subgroup-analysis-of
-pathological-regression-rate-and-hpv-clearance-rate-at-6-months-in-different
-age-groups-of-the-non-surgical/
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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 (https://classic.clinicaltrials.gov/ct2/show/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: [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]
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