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FG001 has completed all toxicity studies successfully


May 28, 2020

Copenhagen, Denmark, 28 May 2020 – FluoGuide is pleased to announce that FG001 has successfully completed all toxicity studies needed to initiate first clinical study in humans, and in a very short time compared to industry standard.

FluoGuide has previously communicated its anticipation of a clean outcome of these studies which has now been confirmed.

FluoGuide decided to conduct a full pre-clinical toxicity program for FG001, including species qualification studies, to document the safety of FG001 best possible before entering human clinical trials. The rationales were to give high priority to patient safety and decrease risk of delay due to prolonged regulatory discussions or requests for additional studies to be done. 

The directed issue conducted in February 2020 allows FluoGuide to accelerate the start of the pivotal study for FG001 by 6-12 months compared to what was promised at the time of the IPO. This was only made possible due to a thoroughly conducted safety program for FG001.

Although, FluoGuide did a full pre-clinical toxicity program for FG001, it was performed in a very short time. Ingrid Brück Bøgh DVM., Ph.D, DVSc being part of an extraordinary team supporting the work explains: “Completing a comprehensive pre-clinical toxicity program including species qualification and submitting a clinical trial application in less than 9 months is very fast compared to industry standard”, and continues, “I am pleased to see the clean outcome of the pre-clinical program, which predicts a low risk of safety findings in the human clinical trial.”

FG001 has now completed all toxicity studies needed to support a first-in-human clinical study. The production of the clinical supply is completed, subject to final product release and labeling. Following a positive meeting with the Danish Medicines Agency, the preparation of the application for the first clinical trial is now being completed as planned.

We anticipate submitting the clinical trial application in June and initiate the study during the autumn 2020. The time from including the first patient until the result for FG001 is short compared to typical drug studies for a number of reasons e.g., only a single dose is needed and the blinding lies in the light used why the results can be reported ongoing. We will therefore continuously report the results from the study throughout 2020. The clinical study is planned to be completed first half 2021. 

“We prioritize to create long term shareholder value by maximizing the outcome for surgery of patients with cancer as much and as fast as possible” says Morten Albrechtsen, CEO of FluoGuide.