FluoGuide announces regulatory approval from Danish Medicines Agency to commence Phase I/II clinical trial with FG001 in guiding surgery of high grade glioma (including glioblastoma)

Press release

September 3, 2020

Copenhagen, Denmark, 3 September 2020 – FluoGuide A/S (“FluoGuide” or “the Company”) is pleased to announce that the company has received regulatory approval for the first clinical phase I/II trial. It is the first time that our lead uPAR targeting product – FG001 – will be used to guide oncology surgery.

FluoGuide appreciates that the Danish Medicines Agency wants to conduct an audit of the clinical trial site at Rigshospitalet to provide priority to patients safety as the clinical trial is a first-in-man with a new chemical entity. The first patient is therefore expected to be included in the study ultimo October. The outlook of the clinical trial remains, otherwise, as described in the latest quarterly report (page 6).

“This certainly marks an important milestone for FluoGuide and we look forward to start the clinical trial and advance our lead product FG001. The trial has no long-term follow-up as the end-point is FG001’s effect in detecting cancer during surgery and we will therefore regularly report on the results of this trial during 2020”, says Morten Albrechtsen, CEO of FluoGuide A/S