FluoGuide A/S Submits Phase II Trial Application for Head and Neck Cancer

KØBENHAVN, Denmark, October 07, 2024 - FluoGuide A/S, a biotechnology firm focused on precision cancer surgery, has announced the submission of a Clinical Trial Application (CTA) for a phase II trial targeting head and neck cancer, specifically oral squamous cell carcinoma. This announcement comes after promising topline data emerged from an earlier phase II proof-of-concept trial with FG001 in patients with this type of cancer. The company is set to discuss the details of the trial in a live streaming event hosted by Redeye on October 18, 2024.

The CTA submission is a critical step towards bringing FG001 to patients and eventually to market. Feedback and discussions with key opinion leaders globally have underscored the significant unmet needs of head and neck cancer patients, informing the comprehensive design of the upcoming clinical trial (CT-005). The company has also gathered input on optimizing FG001’s positioning from regulatory, partnering, and commercial standpoints.

The trial design has been developed in close collaboration with regulatory and clinical experts, including the Principal Investigator, Prof. Dr. Max Witjes. The phase II trial (CT-005) will be a single-center study aimed at:

Initial interim data are anticipated in the second half of 2025. Based on the results and regulatory feedback, FluoGuide plans to proceed with a multisite registration trial, paving the way for approval and commercialization.

FluoGuide will present the trial and its future prospects at a live event on October 18, 2024, featuring an interview with CEO Morten Albrechtsen and CSO Andreas Kjær by Redeye analyst Christian Binder.

FluoGuide is a biotech firm that focuses on enhancing surgical precision in cancer treatment. Its leading product, FG001, aims to improve surgical accuracy by illuminating cancer cells with fluorescent light that binds to the uPAR receptor, commonly found in various solid tumors. This technique is expected to reduce local recurrence rates and surgical complications, ultimately enhancing patient outcomes and reducing healthcare expenses. Additionally, FluoGuide's technology has potential applications in photothermal therapy (PTT), which uses near-infrared light to heat and kill cancer cells while sparing healthy tissue, offering a direct therapeutic benefit.

FluoGuide is publicly traded on the Nasdaq First North Growth Market in Stockholm under the ticker "FLUO."

Head and neck cancers, including those affecting the head and neck regions, often pose significant surgical challenges. These cancers, typically squamous cell carcinomas, are the sixth most prevalent cancer type globally. Annually, around 950,000 new cases are diagnosed worldwide, with approximately 450,000 deaths. In the USA and EU, head and neck cancers account for about 63,000 and 136,000 new cases each year, respectively.

These cancers are frequently difficult to remove entirely or with adequate safety margins, necessitating follow-up treatments like chemoradiotherapy, which can produce serious short- and long-term side effects. The proximity of these cancers to vital structures such as blood vessels and nerves, as well as cosmetic considerations, makes surgical precision crucial. Advanced surgical techniques are essential to improve patient outcomes and reduce the need for additional treatments.

In summary, FluoGuide's upcoming phase II trial for FG001 in head and neck cancer is a significant milestone in the company's mission to advance precision cancer surgery. The trial aims to validate the effectiveness of FG001 in improving surgical outcomes and sets the stage for subsequent regulatory approval and commercialization.