FluoGuide A/S provided an update on its corporate strategy and plans for further clinical development and commercialization of its lead product FG001. FluoGuide has obtained clinical proof of concept of FG001, a fluorescent molecule targeting the cancer specific uPAR receptor, which lights up cancer cells to improve outcomes of surgery. This includes positive phase II data across three indications: aggressive brain cancer (high grade glioma), head & neck cancer, and lung cancer.
FG001 has been granted U.S. Orphan Drug Designation in aggressive brain cancer (high grade glioma). Based on this strong foundation, FluoGuide plans to expand the scope of application of FG001 and advance its development toward approval in aggressive brain cancer. Photothermal therapy (PTT) using FG001 has the potential to selectively eliminate cancer cells with a notable sparing of surrounding normal tissue and represents a significant commercial opportunity.
FluoGuide has decided to evaluate FG001's potential in PTT in aggressive brain cancer. FluoGuide plans to advance FG001 into the first clinical trial for registration of FG001 in fluorescence guided surgery (FGS) of aggressive brain cancer, based on feedback from the U.S. Food and Drug Administration (FDA). The benefit of potentially including a treatment effect from PTT in the development of FG001 in this indication will offer considerable potential additional value, significantly reducing the combined development costs for FGS and PTT, which will more than outweigh a delay to the start of regulatory trial.
FluoGuide also aims to initiate a phase II trial in head & neck cancer as it offers several valuable positionings of FG001 for patients as well as several partnering opportunities. Hence FluoGuide will explore partnering options across indications with manufacturers of imaging systems, with the aim of accelerating and expanding the commercial opportunities while retaining the maximum value for its shareholders.