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FluoGuide updates its corporate strategy

FluoGuide plans to expand the scope of application of FG001 and advance its development toward approval in aggressive brain cancer.

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).

Aggressive brain cancer

Based on this strong foundation, the company has now announced that it plans to expand the scope of application of FG001 and advance its development toward approval in aggressive brain cancer.

We engage in dialogue with regulators on the design of this trial, which is expected to start in 2025.”

“FluoGuide made excellent progress in 2023 and now we are setting out our plans to improve outcomes of surgery for cancer patients. We will expand the scope of our lead product FG001 through increasing both the number of patients we assist and the benefits they experience, while improving the probability of success by mitigating risks, and thereby enhancing shareholder value,” says Morten Albrechtsen, CEO of FluoGuide. “Specifically, we are examining the possibility of expanding the development trials of FG001 in brain cancer to include photothermal treatment of cancer, as well as guiding surgery. This could bring considerable benefit to patients and is a considerable potential market, and we engage in dialogue with regulators on the design of this trial, which is expected to start in 2025.”

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, the company states.

Partnering opportunities

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.

“We are preparing a phase II trial in head & neck cancer, which provides a wide range of opportunities to generate value. These plans build on a position of strength, with robust clinical data in hand from three indications and a comfortable financial position with a low fixed rate of cash burn, which allows us to optimize funding and partnerships,” says Morten Albrechtsen.

FluoGuide is also advancing the development of CMC (Chemistry, Manufacturing, and Controls) and non-clinical development to allow a timely regulatory package for submission of the New Drug Application (NDA) for FG001.

Photo: iStock

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