In the phase IIb trial, FG001 is being tested as a standalone treatment compared to Gliolan (5-ALA), which is the only approved product for intraoperative guidance during aggressive brain cancer surgery. 24 patients will be randomized 1:1 against Gliolan (5-ALA). The primary endpoint of the phase IIb trial measures the proportion of patients with relevant change in clinical strategy, which is aligned with regulatory position for pivotal trials in fluorescence guided surgery. The trial aims to demonstrate non-inferiority to 5-ALA, and the result will be used to calculate the number of patients needed for the phase III trial. The trial is not powered to show significance.

The patients are being recruited at two sites: Linköping, Sweden and Copenhagen, Denmark. The results of the phase IIb trial are expected to be available in H1 2023.

The phase IIb trial follows the highly promising phase I/IIa results in aggressive brain cancer (high grade glioma) that FluoGuide announced in April 2022. FG001 was demonstrated to be well tolerated with only few patients reporting mild side effects (3 out of 40 patients). Furthermore, 100% of the biopsies from patients in the optimal dose (n=8, with 33 biopsies obtained) showed cancer illumination with high sensitivity and specificity.

Morten Albrechtsen, CEO says: “I am very pleased that the important IIb trial in patients with aggressive brain cancer is progressing as planned””.