FluoGuide A/S, a Danish biotech company, has announced positive interim results from the phase IIa trial of its lead product FG001 in head & neck cancer. FG001 was shown to illuminate tumors in all of the patients.
Data show all 12 patients in the first two cohorts, undergoing surgery for head & neck squamous cell carcinomas (HNSCC), had their tumors lit up with FG001. FG001 is a fluorophore targeting uPAR, a cancer specific target expressed extensively in most solid cancers. The fluorophore has the same spectral specifications as indocyanine green, which is already approved, and this means FG001 can be used on current imaging equipment without adaptation.
It is administered into a patient’s vein prior to surgery and lights up the cancer during surgery, helping to guide the surgeon in removing all cancer while sparing healthy tissue.
The third cohort of a further four patients has been initiated on a low dose of FG001 to enable investigation of a broad dose range, which will inform dose selection for a future phase IIb trial. It is, therefore, expected that some cancers in the third cohort of patients will not light up.
“We are pleased to report another positive set of results with FG001, our imaging agent for guiding cancer surgery. We are building up a broad data set showing FG001 is effective across a range of cancers and this, combined with its compatibility with different types of imaging equipment, means it has the potential to significantly improve the outcome of surgery for these patients, with tumors removed more precisely while leaving healthy tissue undamaged,” said Morten Albrechtsen, CEO of FluoGuide.
“We will now prepare the next steps for development of FG001 over the coming months, considering data from all three indications – lung, head & neck and aggressive brain cancers – and potential partner interest.”
FluoGuide expects enrollment of the last patient in its phase IIb trial of FG001 in aggressive brain cancer (high grade glioma) during the summer of 2023 and the topline result approximately two months after that. The topline result from the phase IIa trial of FG001 in head & neck cancer is expected in H2 2023.
About head and neck cancer
Head and neck cancer includes cancers in the lining of the lips, tongue, mouth, or upper throat. Head and neck cancer is often occurring in close anatomical proximity to small vital structures such as blood vessels supplying the brain and many important nerves. Further, cosmetic considerations are important for most locations of head and neck cancers. Surgical precision is, therefore, essential for surgical removal of head and neck cancers. Most head and neck cancers arise from squamous cells and are called squamous cell carcinomas.
Worldwide, head and neck cancer accounts for approximately 900,000 cases and over 400,000 deaths annually. It is the 6th most common cancer. In the U.S. and EU, head and neck cancer accounts for approximately 66,000 cases annually and 15,000 deaths, and 250,000 cases and 63,500 deaths, respectively.
Several companies presented results from promising trials in the fight against head and neck cancer at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago recently.