FluoGuide has reported positive topline efficacy and safety results in the 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 Skjøth-Rasmussen, Chief Physician in the Department of Neurosurgery at Rigshospitalet, Copenhagen, Denmark and Principal Investigator of the trial.
“FluoGuide has reached a major landmark in its development. The positive completion of this phase IIb trial in brain cancer following the recent U.S. Orphan Drug Designation in the same indication, sets the stage for further clinical development of FG001 and for defining our strategy towards commercialization,” says Morten Albrechtsen, Chief Executive Officer of FluoGuide.
About 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.
“These results are in line with our expectations of a safe and effective drug and the data generated will be used for the optimal design of the next stage clinical development. We have positive phase II data on FG001 in three indications – aggressive brain, head & neck and lung cancers – which provide multiple options for routes to market,” says Andreas Kjaer, Chief Scientific Officer of FluoGuide.
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.
Photo of Morten Albrechtsen, Chief Executive Officer of FluoGuide: FluoGuide