FluoGuide has received approval from the Danish Medicines Agency to initiate phase II trial with FG001 in head and neck cancer

Copenhagen, Denmark, 6 September 2022 – FluoGuide A/S (“FluoGuide” or the “Company”) is delighted to announce that the company has received approvals to initiate the phase II trial in head and neck cancer. The trial is expected to enrol first patient in Q4 2022.

Following the approval from the Danish Medicines Agency, FluoGuide is initiating 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. (Please see latest article in ONCOLOGY REPORTS 48: 147, 2022).

Christian von Buchwald, MD, DMSc, Professor, Department of Otolaryngology, Head & Neck Surgery and Audiology says” FG001 has a very promising profile in lighting up cancer” and continues” although you as a surgeon get a CT or MRI scan for pre-operative planning in order to help pinpoint areas of cancerous tissue, it is never easy to assess how much to remove during the operation, and we are therefore very focused on using new tools to help us performing precise surgery”.

Principal investigator Anders Christensen, MD, Ph.D. says” uPAR has been shown to be strongly expressed in head and neck cancer. Therefore, FG001 targeting uPAR is a very interesting technology to allow visualization of tumours in this type of cancer. I am very excited to be the first surgeon to test FG001 in patients with head and neck cancer.”