FluoGuide A/S announced positive topline results from a phase IIa trial of its lead product FG001 in lung cancer. FG001 was shown to illuminate the majority of the patients' lung tumors and was well tolerated in all patients. These results support further clinical development in this indication.

FG001 was shown to light up lung cancer in 73% of the patients and was safe and well tolerated. This marks the third cancer indication for which FG001 shows efficacy, underscoring its potential for broad applicability. Further data in brain and head & neck cancers are expected in H2-2023.

FG001 is a fluorophore targeting uPAR, which is a cancer specific target expressed extensively in most solid types of cancers. The fluorophore has the same spectral specifications as indocyanine green, which is already approved, and this means FG001 can be used on current imaging equipment without adaptation. It is injected into a patient's vein prior to surgery and lights up the cancer during surgery, helping to guide the surgeon in removing all cancer while sparing healthy tissue.

A total of 15 patients with non-small cell lung cancer (NSCLC), undergoing lung surgery (lobectomy), completed the trial, with a gender distribution of 9 females and 6 males a weight range of 50-92 kg and age range of 50-83 years. FG001 was shown to be safe and well tolerated in all patients. The pharmacokinetic (PK) profile for FG001 was determined in lung cancer patients and the half-life (t1/2) was found to be comparable with that of aggressive brain cancer (high grade glioma).

Globally, 2.2 million individuals are diagnosed with lung cancers annually and 1.8 million patients die every year with lung cancer. It is the second most commonly diagnosed type of cancer and the leading cause of cancer death in 2020. lung cancer is typically diagnosed when the cancer already has spread being an important reason for its high mortality.