Photocure Partner Asieris Announces Completion of Patient Enrollment in Cevira Phase III Clinical Trial

Rhea-AI Summary

On August 9, 2022, Asieris Pharmaceuticals announced that the multinational Phase III Clinical Trial of APL-1702 (Cevira^®) has successfully enrolled 402 patients, surpassing its enrollment target two months ahead of schedule. This trial focuses on a non-surgical treatment of cervical high-grade squamous intraepithelial lesions (HSIL). Furthermore, Photocure received a $1 million milestone payment from Asieris for the ongoing development of Cevira, which addresses a significant unmet need in treating HSIL.

Positive

• Successful enrollment of 402 patients in Phase III trial two months ahead of schedule.
• $1 million milestone payment received from Asieris for Cevira's clinical development.

Negative

• None.

OSLO, Norway, Aug. 9, 2022 /PRNewswire/ -- On August 9, 2022, Asieris Pharmaceuticals, a global biopharmaceutical company specializing in the discovery and development of innovative drugs for the treatment of genitourinary tumors and other major diseases, announced that the multinational Phase III Clinical Trial of APL-1702 (Cevira^®), a novel non-surgical treatment of cervical high-grade squamous intraepithelial lesions (HSIL), has successfully enrolled 402 patients in the study two months ahead of schedule. Additionally, Photocure received a $1 million milestone payment from Asieris related to the ongoing clinical development of Cevira.

APRICITY is a multicenter, prospective, double-blind, randomized controlled Phase III study further evaluating the efficacy and safety of the integrated drug-and light-delivery device Cevira^® in the treatment of HSIL. The clinical trial was approved by the National Medical Products Administration (NMPA) in July 2020 and was conducted simultaneously at 65 sites in 8 countries including China, Germany, Hungary and the Netherlands. The first patient was dosed in November 2020.

Cervical cancer is the fourth most common cancer in women worldwide¹. In 2020, 604,000 new cases and 342,000 deaths worldwide were attributed to cervical cancer.^1,2 Current treatments of HSIL of the cervix are based on invasive surgical interventions, compromising cervical competence and functionality. Currently, no non-surgical approach is available for the treatment of precancerous cervical lesions.

Read Asieris' full press release here: https://asieris.com/asieris-multinational-phase-iii-clinical-trial-for-the-non-surgical-treatment-of-hsil-has-completed-enrollment/

1. Cervical cancer. Available from: https://www.who.int/health-topics/cervical-cancer

2. 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

Note to editors:

All trademarks mentioned in this release are protected by law and are registered trademarks of Photocure ASA

About Cevira^®:

Cevira is a breakthrough photodynamic drug-device combination product that is being developed for non-surgical treatment of high-grade precancerous lesions of the cervix. Cevira holds the potential to serve the high unmet medical need for non-invasive treatment options for patients with HSIL in an outpatient setting, especially for young women of reproductive age. Asieris Pharmaceuticals entered into a license agreement with Photocure ASA (Photocure, PHO: OSE) to obtain the worldwide development and commercialization of Cevira in July 2019. Cevira^® is a registered trademark of Photocure ASA, based in Oslo, Norway.

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

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SOURCE Photocure

FAQ

What is APL-1702 (Cevira) in relation to PHCUF?

APL-1702 (Cevira) is a novel non-surgical treatment for cervical high-grade squamous intraepithelial lesions (HSIL) being developed by Asieris Pharmaceuticals.

What were the results of Asieris' Phase III clinical trial for Cevira?

Asieris successfully enrolled 402 patients in the Phase III clinical trial, completing it ahead of schedule, which indicates strong progress in development.

How does the milestone payment impact Photocure's business?

The receipt of a $1 million milestone payment from Asieris demonstrates advancing collaboration and supports Photocure's financial position.

What is the significance of the Cevira treatment for cervical cancer?

Cevira addresses a significant unmet medical need for a non-invasive treatment option for precancerous cervical lesions, particularly beneficial for women of reproductive age.

When did the enrollment for the Cevira trial begin?

The first patient in the Cevira trial was dosed in November 2020, following trial approval in July 2020.