FluoGuide has received approval from the Danish Medicines Agency to initiate phase II trial with FG001 in lung cancer

Copenhagen, Denmark, 24 March 2022 – FluoGuide A/S (“FluoGuide” or the “Company”) is delighted to announce that the company has received approvals to initiate the phase II trial in lung cancer. The trial is expected to enrol first patient in Q2.

Following approval from the Danish Medicines Agency and Ethical Committee, FluoGuide will initiate enrolment a 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 aggressive brain cancer. 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.

“We are pleased to get started together with Rigshospitalet on this important indication for FG001” says Morten Albrechtsen, CEO and continues “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”