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FluoGuide develops surgical solutions that is expected to reduce suffering for the patient and increases the likelihood of cure as well as reducing costs for the health care system.

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FluoGuide proceeds to seventh dose level (36 mg) with FG001 in the ongoing clinical phase I/II trial following continued improvement of tumor illumination with increasing doses

Regulatory


September 14, 2021

Copenhagen, Denmark, 14 September 2021 – FluoGuide A/S (“FluoGuide” or the “Company”) is pleased to announce that FG001 was well tolerated, and light was detected in all patients in the sixth cohort (24 mg), administered in the morning before surgery. The data from the sixth dose (24 mg) showed a continued improvement and clear illumination of the tumors in all three patients. The dose escalation committee has therefore recommended to initiate the seventh dose level (36 mg) in the ongoing clinical phase I/II trial.

FluoGuide is conducting a clinical phase I/II trial evaluating safety and efficacy of its lead asset, FG001, in patients with aggressive brain cancer (high grade glioma) undergoing neurosurgery. The Company is pleased to announce that FG001 was well tolerated, and an increased illumination of the tumors were detected in all three patients at the sixth dose level (24 mg), administered in the morning before surgery. Based on the strong data, the Company has decided to generate additional safety and dose-selection data by testing 36 mg the morning before surgery, which has been approved by the dose escalation committee. Regarding the illumination, the protocol is designed to continue dose escalation as long as illuminations improve. As this has continuously been observed including with the latest dose of 24 mg, the dose escalation will continue to the next dose level of 36 mg.

 “Also, with the latest dose of 24 mg FG001 we observed a further improvement in tumor illumination” says Morten Albrechtsen, CEO and continues: “Based on this, we therefore continue to the next dose level of 36 mg in order to establish the optimal dose to be used in the second part of the ongoing trial as well as in the upcoming pivotal trials. Only by a thorough dose escalation and study of the optimal dose, we can be sure to fully unfold the potential of FG001 as a tool to improve cancer surgery”.

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 14-09-2021 08:02 CET.