FluoGuide has submitted a Clinical Trial Application (CTA) to the Danish Medicines Agency to initiate phase II trial with FG001 in head and neck cancer

Copenhagen, Denmark 23 August2022– FluoGuide A/S (“FluoGuide” or the “Company”) is delighted to announce that the company has submitted a CTA to initiate a phase II trial in head and neck cancer. The clinical trial will be conducted at Rigshospitalet in Denmark.

Following approval from the Danish Medicines Agency, FluoGuide will initiate the phase II trial in collaboration with Department of Otolaryngology, Head & Neck Surgery and Audiology at the University Hospital, Rigshospitalet, in Denmark. Principal investigator is Anders Christensen, MD, Ph.D.

The phase IIa trial is designed to obtain proof-of-concept in head and neck cancer for our uPAR platform technology used to guide surgical removal of cancer. The plan is to enrol up to 16 patients. The primary endpoint is sensitivity defined as the relative number of patients, where FG001 lights up the cancer confirmed by histopathology. FluoGuide expects top line results to be available in 1H 2023. FluoGuide has selected head and neck cancer due to a high unmet need, and evidence of uPAR being overexpressed in these cancers.

Morten Albrechtsen, CEO says” Following our strong proof-of-concept result of FG001 in high grade glioma, this trial is a continuation of our intention to elucidate the magnitude of commercial potential for FG001 in multiple cancer types”