FluoGuide has released promising top-line outcomes from its phase IIa trial investigating FG001 for lung cancer treatment

Thursday, June 08, 2023

FluoGuide A/S, a Danish biotech company specializing in precision cancer surgery, is pleased to announce positive topline results from a phase IIa trial of its lead product, FG001, in the treatment of lung cancer. The trial demonstrated that FG001 effectively illuminated lung tumors in the majority of patients and was well tolerated.

The findings support further clinical development of FG001 in lung cancer, adding to its demonstrated efficacy in three different cancer indications. This highlights the broad applicability of FG001 in cancer treatment. Additional data from FG001 trials in brain and head & neck cancers are expected in the second half of 2023.

FG001 is a fluorophore that targets uPAR, a cancer-specific marker found extensively in solid tumor types. With spectral specifications similar to the approved indocyanine green, FG001 can be used with existing imaging equipment without modifications. It is administered intravenously before surgery and helps guide surgeons by illuminating cancerous tissues, enabling precise tumor removal while preserving healthy tissue.

In the phase IIa trial, 73% of patients with non-small cell lung cancer (NSCLC) had their tumors illuminated by FG001. The drug demonstrated a favorable safety profile and was well tolerated by all patients. The trial included 15 patients undergoing lung surgery (lobectomy) with a gender distribution of 9 females and 6 males. The age range was 50-83 years, and the weight range was 50-92 kg.

FluoGuide's CEO, Morten Albrechtsen, expressed excitement about the positive results and the potential of FG001 in improving surgical outcomes for lung cancer patients. The company looks forward to upcoming data from FG001 trials in head and neck cancers and aggressive brain cancer. Morten Albrechtsen also mentioned plans to assess further development steps for FG001 based on the accumulated data and potential interest from partners.

René Horsleben Petersen, Professor and Chief Thoracic Surgeon at Rigshospitalet and Principal Investigator of the lung cancer study, emphasized the significance of FG001 in improving surgery and outcomes for lung cancer patients. Petersen welcomed the approval of a pilot project for lung cancer screening in Denmark, highlighting the importance of early diagnosis in improving prognosis.

Globally, lung cancer is a major health concern, with millions of new cases and deaths each year. Implementing screening programs for early detection has been shown to increase survival rates. FluoGuide's ongoing clinical trials and the promising results from the phase IIa trial of FG001 in lung cancer contribute to the advancements in lung cancer treatment.

FluoGuide expects to complete enrollment of the last patient in the phase IIb trial of FG001 for aggressive brain cancer (high-grade glioma) during the summer of 2023, with top-line results anticipated approximately two months later. Interim results from the phase IIa trial of FG001 in head and neck cancer are also expected in the first half of 2023.

FluoGuide's CEO Morten Albrechtsen and CSO Andreas Kjaer will be presenting the lung cancer trial results on June 8th, 2023, at 09:00 AM CEST. The presentation will be distributed by Redeye, and inquiries can be directed to [email protected] or to Christian Binder, an analyst at Redeye.



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