FluoGuide A/S submits Clinical Trial Application for phase II trial in head and neck cancer

Copenhagen, Denmark - FluoGuide A/S (“FluoGuide” or the “Company”), a biothech company specializing in precision cancer surgery, today announced the submission of the Clinical Trial Application (CTA) for phase II trial in head and neck cancer (oral squamous cell carcinoma cancer). Redeye will host a live streaming event regarding the head and neck trial on 18 October 2024, at 10:00 am CET.

The CTA submission follows strong clinical topline data for FG001 tested in a proof-of-concept phase II clinical trial in patients with head and neck cancer and is a step on the path to the patients and commercialization.

Feedback from and discussions with key opinion leaders around the globe, has confirmed the ample needs patients with head and neck cancers have and led to a detailed understanding of the clinical trial design. Additionally, the Company obtained feedback on how to optimize the positioning of FG001 from a regulatory, partnering and commercial perspective to fully utilize the opportunities, condensed in the design of the trial (CT-005).

Regulatory and clinical evaluation and discussions with Principal Investigator, Prof. Dr. Max Witjes, has led to the submitted trial design. The phase II trial (CT-005) is designed as a single center trial to:

• Evaluate multiple end-points with clinical applications of FG001 in patients undergoing surgery for head and neck cancer
• Prepare utilization of different kind of surgical equipment
• Enroll 25-30 patients, with first patient planned to be enrolled in Q1 2025, and last patient expected enrolled in H2 2026

First interim data are expected in H2 2025. Depending on data from the trial and feedback from regulatory authorities, the Company is planning to do a multisite registration trial as the next step supporting approval and subsequent commercialization.

FluoGuide will review the trial and its outlook at a live streaming event hosted by Redeye on 18 October 2024, at 10:00 am CET, where Redeye analyst Christian Binder will interview CEO Morten Albrechtsen and CSO Andreas Kjær.