FluoGuide Receives Approval for Phase II Trial in Head and Neck Cancer

FluoGuide A/S has announced the approval from the Danish Medicines Agency to start a phase II trial for its product FG001, targeting head and neck cancer. This trial, in collaboration with the Department of Otolaryngology, Head & Neck Surgery and Audiology at the University Hospital, Rigshospitalet, Denmark, aims to validate the uPAR platform technology's efficacy in guiding the surgical removal of cancer. Principal investigator Anders Christensen, MD, Ph.D., highlights the potential of FG001 in visualizing tumors, given the overexpression of uPAR in head and neck cancers.

The phase IIa trial is designed to assess the sensitivity of FG001 in lighting up cancer, confirmed by histopathology, with the goal of enrolling up to 16 patients. The trial's primary endpoint is to determine the relative number of patients where FG001 successfully illuminates cancerous tissue. FluoGuide anticipates the availability of top-line results by the first half of 2023.

Christian von Buchwald, MD, DMSc, Professor at the Department of Otolaryngology, Head & Neck Surgery and Audiology, emphasizes the challenges surgeons face in determining the extent of tissue removal during operations and the promising role of FG001 in enhancing surgical precision. The selection of head and neck cancer for this trial is based on the high unmet need in this area and the evidence of uPAR overexpression in these cancers.

Head and neck cancer, which includes cancers of the lips, tongue, mouth, and upper throat, poses significant challenges due to its proximity to vital structures and the importance of cosmetic outcomes. Surgical precision is crucial for effective treatment, highlighting the potential impact of FluoGuide's technology on improving patient outcomes and reducing healthcare costs.

This initiative is part of FluoGuide's broader effort to maximize surgical outcomes in oncology, with FG001 representing a significant advancement in intraoperative cancer visualization. The company's focus on head and neck cancer, along with other severe cancer indications, underscores its commitment to addressing critical needs in cancer treatment.