• All patients (12/12) receiving FG001 had additional cancer detected by optical guidance

• FG001 was safe and well tolerated in all patients

K?BENHAVN, DENMARK / ACCESSWIRE / November 13, 2023 / FluoGuide A/S (STO:FLUO) FluoGuide A/S ("FluoGuide" or the "Company"), a pioneer in the cutting-edge field of precision cancer surgery, today announced positive topline efficacy and safety results in the phase IIb trial with the lead product FG001 for guiding surgery in aggressive brain cancer (high-grade glioma).

"I am pleased with this first result of FG001 efficacy in aggressive brain cancer. Here is a promising drug and we should now define the best use of it for the benefit of our patients" says Jane Skj?th-Rasmussen, MD, PhD, Chief Physician in the Department of Neurosurgery at Rigshospitalet, Copenhagen, Denmark and Principal Investigator of the trial.

The controlled, randomized, multi-center phase llb trial (FG001-CT-001) investigated the effect of FG001 in guiding surgery of patients with aggressive brain cancer and compared FG001's effect to 5-ALA. The patients were randomized 1:1 to FG001 or 5-ALA. Fluorescence-guided surgery using FG001 or 5-ALA were compared to white light surgery with each patient serving as its own control. The trial was not designed to show statistical difference (superiority, non-inferiority). The results are used to plan further clinical development.

The topline results are:

• All patients receiving FG001 (12/12) or 5-ALA (12/12) had additional cancer detected by optical guidance, showing FG001 was superior to white light

• FG001 was safe and well tolerated with 2 mild (grade 1) related adverse events

• FG001 lit up 12/12 patients' cancer with a tumor to background ratio (TBR) larger than 2

• No statistically significant differences were observed between FG001 and 5-ALA in histopathology (sensitivity, specificity, negative predictive value and positive predictive value) or gross total resection (GTR) measured on MRI

• Pharmacokinetics of FG001: T1/2 was 13 hours and Cmax was 9.35 mg/L

FG001 is a fluorophore targeting uPAR, which is a cancer-specific target expressed extensively in most solid tumors. It is injected 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 fluorophore has the same spectral specifications as indocyanine green (ICG), which is an approved compound used clinically. Accordingly, FG001 can be visualized with ICG compatible imaging systems.