FluoGuide has submitted a Clinical Trial Application (CTA) to the Danish Medicines Agency to initiate phase II trial with FG001 in lung cancer

Copenhagen, Denmark, 22 December 2021 – FluoGuide A/S (“FluoGuide” or the “Company”) is delighted to announce that the company has submitted a CTA to initiate the phase II trial in lung cancer. The clinical trial will be conducted at Rigshospitalet in Denmark.

Following approval from the Danish Medicines Agency, FluoGuide will initiate the phase II trial in lung cancer in collaboration with Department of Cardiothoracic Surgery at the University Hospital, Rigshospitalet, in Denmark.

The phase II trial is designed to enrol up to 24 patients with non small cell lung cancer (NSCLC). The primary endpoint is sensitivity defined as the relative number of patients, where FG001 lights up the cancer. FluoGuide expects the patients to be enrolled during 2022 and top line results to be available late 2022. The trial includes 2 interim evaluations after 8 and 16 patients, respectively.

FluoGuide has selected lung cancer as the second indication to investigate after malignant glioma. The selection of lung cancer is due to a high unmet need, evidence uPAR being overexpressed in the lung cancer and that the surgeons are familiar with using optical endoscopes during surgery.

“Lung cancer is the second most frequent form of cancer worldwide and the deadliest. Early detection and lung sparring minimal invasive surgery is key for survival and quality of life” says principal investigator and professor René Horsleben Petersen, MD PhD and continues: “This requires precise surgery, and I have a great expectation of studying the effect of FG001 in guiding future lung cancer surgery.”

Due of the flare up of the ongoing COVID-19 pandemic, it may result in delay of regulatory approval and thus the patient inclusion.