FluoGuide invites to presentation of FG001 results from trial in aggressive brain cancer on 17 May

Copenhagen, Denmark, 6 May 2022 – FluoGuide A/S (“FluoGuide” or the “Company”) invites to a presentation of the results from the clinical trial of FG001 used to guide surgery in patients with aggressive high-grade glioma brain cancer, which will first be presented at the 68th Scandinavian Neurosurgical Society (SNS) Congress held 14-16 May 2022, in Bergen, Norway

As a follow-up on the presentation done by Principal Investigator and Chief Surgeon Jane Skjøth-Rasmussen in Bergen, FluoGuide hereby invites to an online presentation of the same data that will be presented at the SNS congress.

Resume of the trial:
In total, 40 patients have been administered FG001 that has been shown to be safe and well-tolerated. No serious drug related adverse events have been reported. Only a few drug-related adverse events were reported as grades 1 or 2, and no pattern or dose relation was observed

The pharmacokinetic (PK) profile for FG001 was assessed for all dose levels. FG001 showed dose-dependent increases in exposure across dose levels in a linear manner.

Tumor-to-background ratio (TBR) is a measure of the contrast. At the optimal dose and time, 36 mg administered the evening before the surgery, all patients revealed a clinically relevant TBR value.

The histology samples from dose 36 mg, evening, and dose 48 mg, evening, have been unblinded and analyzed. The histology results confirm that FG001 lights up aggressive brain cancer.