FluoGuide A/S announced that the company has enrolled the first patient in the phase IIa trial with FG001 in head and neck cancer. The ongoing phase IIa trial is conducted in collaboration with Department of Otolaryngology, Head & Neck Surgery and Audiology at the University Hospital, Rigshospitalet in Denmark. The phase IIa trial is designed to obtain proof-of-concept in head and neck cancer for uPAR platform technology used to guide surgical removal of cancer.

The primary endpoint is sensitivity defined as the relative number of patients, where FG001 lights up the cancer confirmed by histopathology. FluoGuide plans to enrol up to 16 patients and the top-line results are expected to be available in H1 2023. FluoGuide has selected head and neck cancer due to a high unmet need, and evidence of uPAR being overexpressed in these cancers.