FluoGuide A/S announced that topline results from the phase IIa trial of its lead product FG001 in guiding surgery in patients with head & neck cancer, confirming positive efficacy and safety, were presented at the International Academy of Oral Oncology (IAOO) 2023 conference in Incheon, South Korea. The open-label, single-center non-randomized explorative phase lla trial investigated the effect of FG001 in guiding surgery of patients with head & neck cancer (oral and oropharyngeal squamous cell carcinomas ? OPSCC).

The purpose was to obtain proof-of-concept in this indication for the uPAR platform technology used to guide surgical removal of cancer. Data from the trial will be valuable to guide further development of FG001 in head & neck cancer including potential clinical benefits. The topline results were: 4 patients were dosed with 4mg, 8 patients were dosed with 16 mg and 4 patients were dosed with 36mg.

The cancer lit up in all patients with a relevant Tumor To Background Ratio (TBR). Safety: No Serious Adverse Events or drug-related Adverse Events were reported. Several applications for potential clinical benefit were hypothesized and will be explored in further trials.