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FluoGuide has received green light to proceed to the next dose level with FG001 in the ongoing clinical phase I/II trial in patients undergoing surgical treatment of high grade glioma.

Regulatory


May 18, 2021

Copenhagen, Denmark, 18 May 2021 – FluoGuide A/S (“FluoGuide” or the “Company”) is pleased to announce that the dose escalation committee has reviewed the data from the fifth dose level and approved initiation of the next dose level.  In addition, the company has received approval to commence with an evening dosing of the fifth dose level with FG001.

The results from the patients in the fifth dose level show, in line with the previous dose levels, that FG001 was well tolerated. The light intensity continues to increase with higher dose levels and light was detected in all patients.

FluoGuide can now in collaboration with the principal investigator chose to either increase the dose level with a morning administration or administer an already tested morning dose in the evening. The Company has decided to proceed with the fifth dose level in an evening administration.

Coming cohorts of patients will initially receive higher doses of FG001 in the morning to assess safety prior to being evaluated in an evening administration,

“The dosing in the evening will add important information and allow us to make an informed decision of the optimal dose to guide surgery in patients with high grade glioma undergoing surgery” says Morten Albrechtsen, CEO

It is important to underline that the first part of the trial must be completed and analyzed before any final conclusions on tolerability and safety profile can be made. It is also important to state that the pathology examination at the end of the first part is needed to confirm that the tissue that lights up is cancer and tissue that does not light up is free of cancer.

There is still a risk that the recruitment of patients over the next months may be slowed down due to the ongoing COVID-19 pandemic but FluoGuide expects to have data from the first part of the trial available within Q3 2021, also being the starting point to apply for new phase II clinical trials in other cancer indications, including a prevalent cancer such as lung or breast cancer.

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 18-05-2021 08:00 CET.