FluoGuide A/S, a biotech company specializing in precision cancer surgery, has announced the submission of a Clinical Trial Application (CTA) for a phase II trial evaluating FG001 in head and neck cancer, specifically oral squamous cell carcinoma. The trial, designated CT-005, is designed as a single-center study to assess multiple clinical applications of FG001 in patients undergoing surgery for this challenging cancer.
The CTA submission follows promising topline data from a proof-of-concept phase II clinical trial of FG001 in head and neck cancer patients. Feedback from key opinion leaders has underscored the significant unmet needs in this patient population, informing the trial's design and FG001's positioning for regulatory approval and commercialization.
Trial Design and Objectives
The phase II trial (CT-005) is structured as a single-center study with the following key objectives:
- Evaluate multiple endpoints related to the clinical applications of FG001 in head and neck cancer surgery.
- Prepare for the utilization of different surgical equipment in conjunction with FG001.
- Enroll 25-30 patients, with the first patient planned for Q1 2025 and the last patient expected in H2 2026.
Interim data from the trial are anticipated in H2 2025. Based on the trial data and feedback from regulatory authorities, FluoGuide plans to conduct a multi-site registration trial to support approval and subsequent commercialization of FG001.
FG001: Enhancing Precision in Cancer Surgery
FG001 is designed to improve surgical accuracy by selectively illuminating cancer cells during surgery using fluorescent light. The compound binds to the uPAR receptor, which is widely expressed in most solid cancer types. By enhancing the visualization of cancer cells, FG001 aims to reduce the incidence of local recurrence and surgical complications, ultimately improving cancer treatment outcomes and reducing healthcare costs.
FluoGuide's technology platform also holds potential for photothermal therapy (PTT), a technique that uses near-infrared light to heat and kill cancer cells while sparing surrounding healthy tissue. This approach offers a direct therapeutic effect of FG001, further benefiting patients undergoing cancer surgery.
The Need for Improved Head and Neck Cancer Treatment
Head and neck cancer, the sixth most common cancer worldwide, includes cancers in the head and neck region. Approximately 950,000 new cases are diagnosed annually, resulting in around 450,000 deaths. In the USA and EU, there are approximately 63,000 and 136,000 newly diagnosed cases each year, respectively.
Complete surgical removal of head and neck cancers is often challenging due to their proximity to vital structures and the need for cosmetic considerations. Incomplete removal often necessitates follow-up chemoradiotherapy, which can cause significant short- and long-term side effects. Surgical precision is therefore crucial for improving outcomes in head and neck cancer treatment.
