FluoGuide has received approval to commence with FG001 in evening dosing in the ongoing clinical phase I/II trial in patients with high grade glioma
Copenhagen, Denmark, 12 May 2021 – FluoGuide A/S (“FluoGuide” or the “Company”) is pleased to announce that the Danish Medicines Agency and Ethical Committee has approved administration of FG001 in the evening before surgery.
The data from the ongoing dose finding trial suggests that background light intensity might be further reduced if FG001 is administered in the evening prior to surgery. This would presumably give an even better image quality and tumor delineation. To ensure that the best possible combination of FG001 dose and time of administration is carried forward in clinical development, the company has therefore made a protocol amendment to explore also evening administration. This allows for a comparison of morning and evening administration during the ongoing phase I/II trial. The protocol amendment has now been approved by the Danish Medicines Agency and Ethical Committee.
“The approval gives us the opportunity to test FG001 in an evening dosing, which will add important information for the subsequent clinical trials” says Morten Albrechtsen, CEO
FG001 is currently being tested at the fifth dose level. The results from the first fourth dose levels showed that FG001 is well tolerated, and the light intensity continues to increase with higher dose levels.
It is important to underline that the first part of the trial must be completed and analyzed before any final conclusions on tolerability and safety profile can be made. It is also important to state that the pathology examination at the end of the first part is needed to confirm that the tissue that lights up is cancer and tissue that does not light up is free of cancer.
Regarding the timeline, there is still a risk that recruitment of patients over the next months may be slowed down due to the ongoing COVID-19 pandemic but FluoGuide expects to have data from the first part of the trial available within Q3 2021.
