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FluoGuide has been awarded a grant together with Rigshospitalet (DK) to conduct a phase II trial with FG001 in patients with less aggressive brain cancers

Regulatory


March 18, 2022

Copenhagen, Denmark, 18 March 2022 – FluoGuide A/S (“FluoGuide” or the “Company”) is pleased to announce a grant of total 945 KDKK to conduct a phase II trial with FG001 in patients with less aggressive brain cancers.

The grant will accelerate the development of FG001 in the treatment of less malignant brain cancers to the benefit of more patients. FG001 has shown promising results in a phase I/II trial, where light was detected and is well tolerated in patients with aggressive cancer (high grade glioma). One patient with meningioma was reported in the trial (see press release from 9 November 2021), indicating that FG001 may light up less aggressive brain cancer as anticipated from the supporting scientific rationale.

Jane Skjøth-Rasmussen, MD, PhD, who is the principal investigator on FluoGuide’s ongoing clinical trial in High Grade Glioma will be the principal investigator in the new phase II trial.  

“The findings in the initial phase I/II trial shows that FG001 also works in meningioma surgery which is very encouraging” says Jane Skjøth-Rasmussen and continues” I see therefore FG001 as a potential guidance tool assisting our work in brain tumor surgery, giving patients the best chances of recovery.”  

A precise removal of meningioma is paramount for the first surgery for several reasons. Meningiomas are considered less aggressive cancer and well-circumscribed that may be removed completely by surgery. Still, even with a WHO grade I meningioma (the most localized) and a Simpson grade 1 removal (most complete removal), the recurrence rate is between 20 – 39% within 10 years. In addition, approximately 27% of patients will after 5 years be unable to perform normal daily activities due to neurological deficits caused by their treatment. And last, approximately half of the aggressive cancers are derived from less aggressive cancers.

The grant is awarded by Life Science Innovation North Denmark (LSI) who is running a” Sundhedsteknologisk Service Program” (SSP) in collaboration with Danish Life Science Cluster.

“We are now broadening out the potential use of FG001 in additional brain cancer indications to the benefit of more patients. says Morten Albrechtsen, CEO and continues “We are very grateful for the support from Life Science Innovation North Denmark because the grant is very important for the possibility to initiate the trial already now”.

The phase II trial is being planned together with Rigshospitalet, Department of Neurosurgery which already is conducting the phase I/II trial in aggressive brain cancer. The trial is expected to be initiated in the second half of 2022.

This disclosure contains information that Fluoguide is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 18-03-2022 10:27 CET.