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FluoGuide announces Phase IIa results

The company has announced 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.

“These encouraging first clinical results, showing that FG001 was able to light up cancer in all head & neck cancer patients in the trial, indicate it could make a significant difference for operating surgeons and their patients. The data suggest several potential applications in head & neck cancer and I look forward to see further results from FG001’s clinical development,” says Anders Christensen, Principal Investigator and head and neck surgeon, who presented the data at the International Academy of Oral Oncology (IAOO) 2023 conference in Incheon, South Korea.


FG001 is a fluorophore targeting uPAR, which is a cancer specific target expressed extensively in most solid cancers. It is administered into a patient’s vein prior to surgery and lights up the cancer during surgery, helping to guide the surgeon in removing all cancer while sparing healthy tissue. The fluorophore has the same spectral specifications as indocyanine green, which is already approved, and means FG001 is compatible with most imaging equipment.


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.

“The result of this first clinical trial of FG001 in head & neck cancer is very promising and reinforces the potential of FluoGuide’s unique uPAR-targeting technology platform. uPAR is extensively expressed in solid cancers, so targeting potentially enables precise removal of cancer tissue. We are now analyzing the data to optimize the value of FG001 to help surgeons and for the benefit of patients with head & neck cancer,” says Andreas Kjaer, Chief Scientific Officer of FluoGuide. “We now have phase IIa data showing efficacy and safety of FG001 across three indications and are looking forward to topline results from our phase IIb trial in aggressive brain cancer, which are expected later in November 2023. Overall, our data provide a very solid foundation for late-stage clinical development as we define our plans and move FG001 towards commercialization.”

Photo of Andreas Kjaer: FluoGuide