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First patient enrolled in the phase I/II clinical trial testing FG001 in patients with high grade glioma

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Copenhagen, Denmark, 9 November 2020 - FluoGuide A/S (“FluoGuide” or “the Company”) is pleased to inform that the first patient today was enrolled in the clinical trial testing safety and efficacy of FG001 in guiding high grade glioma surgery.

FluoGuide’s phase I/II clinical trial, testing FG001 in patients with high grade glioma consists of two phases; (1) a dose escalation phase to establish safety and proof-of-concept, and (2) an efficacy assessment phase. The total number of patients in the entire phase I/II trial will be up to 36 patients.

FluoGuide is pleased to inform that the first patient has now been enrolled in the dose escalation phase of the clinical trial. The results will be evaluated and made available as earlier communicated in the Company’s interim report from second quarter, published in August 2020. The interim report is available on FluoGuides website www.fluoguide.com.

For further information:
Morten Albrechtsen, CEO
M: +45 24 25 62 66
ma@fluoguide.com

About FluoGuide

FluoGuide’s primary focus is to maximize surgical outcomes in oncology. The Company’s first product, FG001, is designed to improve surgical precision by illuminating cancer cells intraoperatively. The improved precision enabled by FluoGuide’s products has a dual benefit – it reduces both the frequency of local recurrence post-surgery and lessens surgical sequelae. Ultimately, these improvements will improve a patient’s chance of achieving a complete cure and will lower system-wide healthcare costs. The Company is undertaking a proof-of-concept clinical trial (phase I/II) to demonstrate the effect of FG001 in patients with high grade glioma including glioblastoma.

This project has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No 954904.

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