Photocure: Asieris Announces First Patient Administration in Europe within the Phase III Clinical Trial for APL-1702 (Cevira)

On June 22, 2021 Photocure ASA (OSE:PHO) reported that its partner Asieris Pharmaceuticals (Asieris) has administered the first European patient in its phase III clinical trial for APL-1702 (Cevira) (Press release, PhotoCure, JUN 22, 2021, View Source [SID1234584253]).

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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 (View Source).

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.