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FluoGuide enters agreement with Swedish university hospital for the second phase of the ongoing FG001 clinical trial


June 30, 2021

Copenhagen, Denmark, 30 June 2021 – FluoGuide A/S (“FluoGuide” or the “Company”) is pleased to announce that the Company has entered into an agreement with the Department of Neurosurgery, Linköping University Hospital, Sweden to become the second site investigating FG001´s effect in guiding surgical removal of aggressive brain cancer. Linköping University Hospital is added to the second phase of the ongoing clinical phase I/II trial.

The ongoing clinical phase I/II trial with FG001 is designed as a two-phase trial, where the first phase aims to identify the optimal dose and investigate safety and tolerability. The second phase 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. Several of the design elements needed in the pivotal phase III trial is included in the ongoing clinical phase I/II trial of FG001 for use in guiding surgery of glioblastoma.

In collaboration with Copenhagen University Hospital (“Rigshospitalet”) in Denmark, FG001 is currently in the first phase of the clinical trial. For the second phase of the clinical trial, Linköping University Hospital will be included to provide diversity to the trial by working with different centers in different counties. Peter Milos (MD) will be the principal investigator at Linköping University Hospital. The Swedish site is expected to start recruiting patients during H2 2021.

“The neurosurgery department of the University Hospital in Linköping, Sweden is well known for its innovative research in the field of neurosurgery and involvement in numerous clinical trials in brain cancer”, says Morten Albrechtsen, CEO and continues “I am also delighted that Peter Milos, who is an experienced and well reputed neurosurgeon, will be the one to lead the trial in Linköping”.

“There is large need for improving the treatment of patients with high grade glioma and I am looking forward to investigate FG001 in guiding surgery of these patients”, says Peter Milos, MD