Precision cancer surgery specialist FluoGuide has announced the successful completion of patient enrolment in its phase lla trial with FG001 in patients with head and neck cancer.
Data shows that cancer lit up in all 16 patients treated in the trial so far, including those receiving a low dose of FG001.
“These new data further confirm the potential of FG001 in guiding surgeons towards removing cancer while leaving healthy tissue. We will now carefully analyse these results, which we expect to be confirmed in the topline data due later this year, as we work to define FG001’s optimal route towards market and making a significant difference to cancer patients. We expect to provide further details on FG001’s development in head & neck cancer later this year,” said Anne Poulsen, Senior Clinical Project Manager at FluoGuide.
FG001 is a fluorophore targeting uPAR, which is a cancer specific target expressed extensively in most solid cancers. The fluorophore has the same spectral specifications as indocyanine green, which is already approved, and this means FG001 can be used on current imaging equipment without adaptation. 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 open-label, single-centre non-randomised explorative phase lla trial investigating the effect of FG001 in guiding surgery of patients with head & neck cancer (oral oropharyngeal squamous cell carcinomas cancer - OPSCC).
Further, the purpose is 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 provide valuable data needed to guide further development of FG001 in head & neck cancer.
New interim results with a low dose of FG001 (4mg) showed that all 4 patients’ cancer lighted up. This means that cancer lit up in all 16 patients treated in the head & neck cancer trial. Preliminary data suggest FG001 was well tolerated in all patients. Topline results, which will give further detail on tumour-to-background ratio, safety, pharmacokinetics and histology are expected in H2 2023 and after topline data from the phase IIb trial of FG001 in brain cancer, due to prioritisation of resources.
"The data underline FluoGuide’s very strong progress in 2023. We have strong clinical data on FG001 in three indications, which is supporting development of plans for late-stage clinical development and defining the optimal path to market and commercialisation,” says Morten Albrechtsen, CEO of FluoGuide.