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FluoGuide announces regulatory approval from Swedish Authorities (MPA and Ethics committee) to commence Phase II clinical trial with FG001 in guiding surgery of high grade glioma in Sweden


August 26, 2021

Copenhagen, Denmark, 26 August 2021 – FluoGuide A/S (“FluoGuide” or “the Company”) is pleased to announce that the company has received regulatory approval for expanding the ongoing clinical phase I/II trial to Sweden with FG001.

The ongoing clinical phase I/II trial with FG001 is designed as a two-phased trial, where the first phase aims to identify the optimal dose and investigate safety and tolerability. Phase II will provide efficacy data that will be used to design the following pivotal phase III trial intended to support regulatory approval of FG001 in high grade glioma, aggressive brain cancer.

After the approval in Sweden, Linköping University Hospital will be the second site investigating FG001´s effect. Sweden and Linköping University Hospital is added to phase II of the clinical phase I/II trial, to provide diversity to the trial by working with different centers in different counties. First patient enrollment is expected after the reporting of phase I of the ongoing I/II clinical trial.

“We look forward to expanding the clinical trial with Peter Milos and his team at Linköping University Hospital” says Morten Albrechtsen, CEO and continues, “We are happy to see that the regulatory process went so smoothly thanks to a very professional effort from the people involved in FluoGuide and Linköping”.