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FluoGuide A/S submits phase I/II Clinical Trial Application

Press release

July 6, 2020

Copenhagen, Denmark, 6 July 2020 – FluoGuide A/S (“FluoGuide” or “the Company”) today submitted a Clinical Trial Application for the proof-of-concept clinical phase I/II trial of FG001 for use in guiding surgery of aggressive brain cancer (glioblastoma).

The preclinical studies needed to support human clinical trials for FG001 have now been completed and reported. The clean outcome of the pre-clinical program predicts a good tolerability profile in human use.

The consultation with the Danish Medicines Agency in May 2020 provided positive feedback and endorsement of FluoGuide’s development plans for initial clinical trials. The Company anticipates the initiation of the clinical trial this upcoming fall. The time from the first patient enrollment to trial results is short for FG001 compared to typical drug trials for a number of reasons, most particularly because only a single dose is administered and the outcome (tumor lightening up) is immediately available. The trial has no long-term follow-up as the end-point is FG001’s effect in detecting cancer during surgery. FluoGuide will therefore regularly report on the results of this trial during 2020. The clinical trial is planned to be completed during the first half of 2021.

The design of the clinical trial contains two phases, where the first phase aims to identify the optimal dose, safety and tolerability, and the second provides efficacy data to design a robust pivotal phase III trial for FG001 in glioblastoma. Several of the design elements needed in the pivotal trial have already been included in this phase I/II trial of FG001 for use in guiding surgery of aggressive brain cancer (glioblastoma). This design is more comprehensive than originally planned and up to 36 patients are included to provide a solid basis for regulatory and clinical development towards market approval.