Photocure: Asieris Announces First Patient Administration in Europe within the Phase III Clinical Trial for APL-1702 (Cevira)
Oslo, Norway, 22 June, 2021: Photocure ASA (OSE:PHO) today announces that its partner Asieris Pharmaceuticals (Asieris) has administered the first European patient in its phase III clinical trial for APL-1702 (Cevira®).
Asieris announced dosing of the first patient in Europe in its multinational, multicenter, Phase III clinical trial called APRICITY that started last November. The photodynamic drug-device combination product APL-1702, Cevira®, licensed to Asieris by Photocure, is being developed for a novel non-surgical treatment of cervical high-grade squamous intraepithelial lesions (HSIL).
“The multinational phase III clinical trial for Cevira is an important milestone towards a non-surgical treatment of high-grade cervical dysplasia. This step shows once more that our partner Asieris is making great progress and is on track with their clinical program and development of this innovative photodynamic drug-device combination,” says Daniel Schneider, Chief Executive Officer of Photocure.
In China, the clinical trial application for APL-1702, Cevira multinational Phase III trial was approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in July 2020. Photocure reported Asieris’ dosing of the first patient in China on November 11, 2020 (https://photocure.com/news/asieris-announces-first-patient-administration-in-the-global-phase-iii-clinical-trial-for-apl-1702-cevira/).
HSIL is a pre-cancerous condition caused by a persistent HPV infection. Each year there are approximately 10 million cases of high-grade disease and over 500,000 new cases of cervical cancer worldwide. In China, approximately 2% of women develop HSIL each year.
Please read Asieris’ full press release here:
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® is a photodynamic drug-device combination product that is being developed for non-surgical treatment of high-grade cervical dysplasia. Cevira is easily placed on the cervix by the gynecologist and removed by the patient, with no disruption of normal daily activities. Only one or two treatments are needed.
About Cervical dysplasia
High grade cervical squamous intraepithelial lesions (HSIL) is a precancerous condition caused by a persistent HPV infection, a highly prevalent sexually transmitted disease resulting in approximately 10 million cases with high grade disease and > 500 000 new cases of cervical cancer each year. In China, approximately 2% of women have HSIL each year. Currently, surgical excision is the most common treatment option offered to women with cervical high-grade dysplasia. In women of childbearing age in particular there is a high medical need for a non-surgical option which preserves the cervical anatomy and function. No such medical alternative is approved to date.
About Photocure ASA
Photocure, The Bladder Cancer Company, delivers transformative solutions to improve the lives of bladder cancer patients. Our unique technology, which makes 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 or www.cysview.com
For more 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
Head of Investor Relations
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