FluoGuide A/S has announced the publication of positive Phase 2 clinical data for its investigational imaging agent, FG001, in Theranostics. The study, titled "Optical molecular imaging in oral- and oropharyngeal squamous cell carcinoma using a novel uPAR-targeting near-infrared imaging agent FG001 (ICG-Glu-Glu-AE105): An explorative phase II clinical trial," highlights FG001's potential to improve surgical precision in patients with head and neck cancer.
FG001: Illuminating Cancer Cells for Enhanced Surgical Accuracy
FG001 is designed to enhance surgical accuracy by selectively binding to the uPAR receptor, which is widely expressed in most solid cancer types, and illuminating cancer cells intraoperatively using fluorescent light. The goal is to reduce the incidence of local recurrence after surgery and surgical complications, leading to improved treatment outcomes and reduced healthcare costs.
Key Findings from the Phase 2 Trial
The Phase 2 trial included 16 patients diagnosed with oral or oropharyngeal squamous cell carcinoma undergoing surgery. Key findings from the study include:
- Efficacy: FG001 successfully illuminated cancerous tissues in all enrolled patients, achieving a 100% sensitivity rate, the primary endpoint of the study.
- Dosage Variability: Consistent results were observed across a broad range of doses (4, 16 and 36 mg per patient).
- Imaging Contrast: The tumor-to-background ratio exceeded 2.0 in all patients with an average of 2.99, significantly above the threshold for usefulness (1.5 – 2.0).
- Tolerability: FG001 demonstrated excellent tolerability, with no drug-related adverse events reported.
- Time Frame for Use: The agent remained effective within the relevant time window, detectable from 2 hours up to at least 19 hours post-administration, based on the longitudinal data.
- Specificity: FG001 was shown to be specific to cancer, as confirmed by the colocalization of FG001 fluorescence and histology.
- Clinical Applications: The trial identified several relevant applications in the surgical workflow for head and neck cancer surgery, including guiding surgery, evaluating surgery (margin detection), and real-time evaluation of lymph node spread.
Management Commentary
Morten Albrechtsen, CEO at FluoGuide, stated, "The publication of these promising results of FG001 in head and neck cancer is a significant milestone for FG001," and added, "The high-rank publication of these interesting clinical data lays out a good foundation for the forthcoming clinical trial planned for start in Q1 next year providing a new and promising help for patients with head and neck cancer."
Future Directions
FluoGuide is planning to initiate a new clinical trial in the first quarter of next year to further evaluate FG001's efficacy in head and neck cancer surgery, building on the positive results from this Phase 2 trial.
