The research company Fluoguide has submitted a clinical trial application (CTA) for a phase 2 study in head and neck cancer. This is stated in a press release.

The application follows strong clinical data for FG001 tested in a proof-of-concept phase 2 study.

The study, which is expected to start in the first quarter of 2025, is designed as a single-center study to include 25-30 patients. The first interim results are expected in the second half of 2025.

The study aims to evaluate the clinical applications of FG001 in patients undergoing surgery for head and neck cancer.

"Depending on data from the study and feedback from regulatory authorities, the company plans to conduct a multi-site registration study as the next step to support approval and subsequent commercialization," the company writes.