FluoGuide A/S, a Danish biotech company specializing in precision cancer surgery, has announced the approval of its Phase II Clinical Trial Application (CTA) for FG001 in head and neck cancer, specifically oral squamous cell carcinoma. This approval paves the way for a study evaluating the drug's ability to enhance surgical precision and improve patient outcomes.
The Phase II trial, designated CT-005, is slated to begin in the first quarter of 2025 at the University Medical Center Groningen in the Netherlands, under the guidance of Principal Investigator Prof. Dr. Max Witjes. The single-center trial aims to enroll 25-30 patients with head and neck cancer to evaluate multiple endpoints related to surgical completeness when using FG001. Researchers will also explore various benefits of FG001 in assisting patients and assess its compatibility with different surgical equipment types.
According to FluoGuide, interim data from the trial is expected in the second half of 2025, serving as a key data trigger point. The trial is anticipated to be fully completed in the second half of 2026. Depending on the trial data and regulatory feedback, FluoGuide plans to conduct a multi-site registration trial as the next step toward approval and commercialization.
FG001: Illuminating Cancer for Precision Surgery
FG001 is designed to improve surgical precision by selectively binding to cancer cells and illuminating them intraoperatively. This mechanism is intended to enable surgeons to more accurately distinguish between cancerous and healthy tissue, potentially leading to more complete tumor resection. The company states that improved precision enabled by FluoGuide’s products is expected to have a dual benefit – it reduces both the frequency of local recurrence post-surgery and lessens surgical sequelae. FG001 binds to the receptor uPAR being extensively expressed on most solid cancer types. The photothermal potential of FG001 could add a direct treatment effect of FG001 to further benefit for patients with cancer undergoing surgery.
Management Commentary
Morten Albrechtsen, CEO of FluoGuide, stated, "The approval is a significant milestone to advance FG001 helping patients with head and neck cancer. We are on track to enroll first patient in first quarter of 2025 and the key data trigger point is expected in the second half of 2025 with the interim data."
About FluoGuide
FluoGuide is focused on improving outcomes for cancer patients through precision surgery. The company's lead product, FG001, is designed to enhance surgical accuracy by making cancer cells visible during surgery. FluoGuide has published results from phase II trials demonstrating the efficacy of FG001 as well as showing it was well tolerated and safe from clinical trials in patients undergoing surgery to remove aggressive brain (high-grade glioma), head & neck and lung cancers. Based on this strong foundation, FluoGuide expands the scope of application of FG001 and advances the development toward approval in aggressive brain cancer.
