Presentation

Company Profile
Fluoguide´s lead product, FG001, improves precision in cancer surgery by lighting up the cancer and its invasive growth into the surrounding tissue. FG001 is made of a cancer targeting molecule linked to a fluorophore. The targeting molecules bind to the urokinase-type plasminogen activator receptor (uPAR). uPAR is extensively expressed by cancer cells and FluoGuide utilizes this fact in the development of FG001. It is currently being evaluated in a phase l/ll trial in patients with glioblastoma undergoing neurosurgery.

Recent highlights
On 17 August, FluoGuide announced that it will proceed to the sixth dose level with FG001 (24mg) in the ongoing clinical phase l/ll trial. FG001 was well tolerated, and light was detected in all patients at the fifth dose level (16mg) administrated in the evening before surgery. FG001 is anticipated to be well tolerated and selection of the dose for use in the part 2 of the trial will therefore be based on optimal illumination of the tumour. The company has now narrowed it down to one of two dose levels (16mg and 24mg).

Outlook
Consolidated safety data will be communicated in Q3 2021 following conclusion of the now initiated 24mg morning dose at the day of the surgery. The optimal dose selection and top-line efficacy from part 1 is expected in Q1 2022. Efficacy results from the second phase enrolling 12 patients are anticipated mid-2022.