FluoGuide A/S, a leader in precision cancer surgery, has provided an update on its corporate strategy and plans for the clinical development and commercialization of its lead product, FG001. FG001 is a fluorescent molecule that targets the cancer-specific uPAR receptor, illuminating cancer cells to improve surgical outcomes. The company has reported positive Phase II data across three indications: aggressive brain cancer (high grade glioma), head & neck cancer, and lung cancer. FG001 has also received U.S. Orphan Drug Designation for aggressive brain cancer.
FluoGuide is exploring the potential of photothermal therapy (PTT) using FG001 to selectively eliminate cancer cells while sparing surrounding normal tissue, offering a significant commercial opportunity. The company plans to initiate a clinical trial for the registration of FG001 in fluorescence-guided surgery (FGS) of aggressive brain cancer, expected to start in 2025, based on feedback from the U.S. Food and Drug Administration (FDA). This trial will assess the benefits of including PTT in the development of FG001, potentially adding considerable value and reducing combined development costs for FGS and PTT.
Additionally, FluoGuide aims to start a Phase II trial in head & neck cancer, exploring various regulatory endpoints and partnerships. This trial will provide a basis for future regulatory clinical trials and expand the commercial opportunities for FG001. The company is focusing its resources on the development of FG001 in brain and head & neck cancers, while continuing to evaluate the commercial opportunity in lung cancer and other indications.
FluoGuide is also advancing the development of CMC (Chemistry, Manufacturing, and Controls) and non-clinical development to prepare a timely regulatory package for the submission of the New Drug Application (NDA) for FG001. The company's strategy aims to improve surgical outcomes for cancer patients, expand the scope of FG001, and enhance shareholder value by mitigating risks and optimizing funding and partnerships.
For further information, FluoGuide's CEO, Morten Albrechtsen, and CSO, Andreas Kjær, will participate in an interview with Redeye on January 10, 2024. The presentation will be available on FluoGuide's website.
