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

Press release

January 13, 2021

Copenhagen, Denmark, 13 January 2021 – FluoGuide A/S (“FluoGuide” or the “Company”) is pleased to announce that the dose escalation committee has approved initiation of the third dose levelin 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 second dose level of FG001, including data from three patients, has 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 third dose level.

The results from the second dose level are in line with data from the first three patients at the first dose level, in respect to safety and tolerability. Light was detected in all three patients at the second dose level. It is important to underline that the trial still is at an early stage, and that the first phase of the trial (up to 24 patients) must be completed and analyzed before any 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 two dose levels, as 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 estimating to meet the following overall timeline remains as earlier 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.

“We need to interpret the initial results with caution, but it is encouraging to see the study advance as planned” says Morten Albrechtsen, CEO.

This information is information that FluoGuide A/S is obliged to publish in accordance with the EU Market Abuse Regulation. The information was provided by the contact person set out above for publication on 13 January 2021.