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FluoGuide gets green light to proceed to fourth dose level with FG001 in the ongoing clinical phase I/II trial in patients with high grade glioma

Regulatory


February 17, 2021

Copenhagen, Denmark, 17 February 2021 – FluoGuide A/S (“FluoGuide” or the “Company”) is pleased to announce that the dose escalation committee have approved initiation of the fourth dose level in the ongoing clinical phase I/II trial evaluating safety and efficacy of FG001 in patients with high grade glioma undergoing neurosurgery.

Evaluation of the results from the third dose level of FG001, including data from three patients, have been finalized and reported to the dose escalation committee. The dose escalation committee has today given their approval to proceed and enroll patients at the fourth dose level.

The results from the third dose level are in line with data from the first six patients at the two first dose levels, in respect to safety and tolerability. Relevant light was detected in two out of three patients at the third dose level. It is important to underline that the trial is still at an early stage, and that the first phase of the trial (up to 24 patients) must be completed and analyzed before any firm conclusions on tolerability and safety profile can be made. It is also important to state that it is not yet possible to establish the efficacy of FG001 on the basis of findings from these first three dose levels although encouraging to see increased signal intensity with increased dose. Further analysis is needed to confirm that the tissue that lights up is actually cancer and tissue that does not light up is free of cancer.

The recruitment of patients over the next months may be slowed down due to the ongoing COVID-19 pandemic.  However, as of now FluoGuide still expects to adhere to the following overall timeline previously communicated: (i) Middle of 2021: Result of first phase (safety and selection of optimal dose), subject to number of cohorts; and (ii) Second half of 2021: Efficacy result from the second phase, including estimation of the potential magnitude of benefit of FG001 in guiding surgery of patients with high grade glioma.

“The study progresses as planned and it is encouraging to see increased intensity as the dose is increased” says Morten Albrechtsen, CEO.

This disclosure contains information that Fluoguide is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 17-02-2021 14:37 CET.