FluoGuide submits clinical trial application for head and neck cancer treatment

Biotech company moves forward with phase 2 trial for precision cancer surgery

Copenhagen-based biotech company FluoGuide A/S has announced the submission of a Clinical Trial Application (CTA) for a phase II trial in head and neck cancer, specifically oral squamous cell carcinoma.

This marks a significant step forward for the company, which specialises in precision cancer surgery. The trial will evaluate the efficacy of FG001, a product designed to enhance surgical accuracy by illuminating cancer cells.

The CTA submission follows promising results from a proof-of-concept phase 2 clinical trial. Feedback from key opinion leaders globally has confirmed the significant needs of patients with head and neck cancers.

This has led to a detailed understanding of the clinical trial design and how to optimize FG001’s positioning from a regulatory, partnering, and commercial perspective.

The phase 2 trial, designated CT-005, will be a single-centre study aiming to evaluate multiple endpoints with FG001 in patients undergoing surgery for head and neck cancer. The trial will enrol 25-30 patients, with the first patient expected to be enrolled in Q1 2025 and the last in H2 2026. Interim data are anticipated in H2 2025.

Discussions with regulatory and clinical experts, including Principal Investigator Prof. Max Witjes, have been instrumental in shaping the trial design. The study aims to provide valuable insights into the clinical applications of FG001.

The company is committed to bringing further treatment options to patients that can improve survival and make a real difference to outcomes for those affected.