FluoGuide A/S | MedPath

FluoGuide Advances Phase II Head and Neck Cancer Trial Following Successful Clinical Results

3 months ago

• FluoGuide has submitted and received approval for a Phase II clinical trial application for FG001 in head and neck cancer, building on previous positive trial results. • The company's earlier Phase II trial demonstrated successful cancer detection with FG001 in all 16 head and neck cancer patients, as published in Theranostics journal. • Despite reporting no revenue and a net loss of DKK 28,959 thousand for 2024, FluoGuide maintains strategic focus on advancing precision surgery through cancer illumination technology.

FluoGuide's FG001 Receives Green Light for Phase II Head and Neck Cancer Trial

4 months ago

• FluoGuide has received approval to begin a Phase II clinical trial of FG001 for head and neck cancer treatment, marking a significant step for the drug's development. • The trial, set to commence in Q1 2025 at the University Medical Center Groningen, will enroll 25-30 patients to assess surgical precision with FG001. • Interim data from the study is anticipated in the second half of 2025, with the trial expected to conclude in the latter half of 2026, informing future pivotal studies. • FG001 aims to improve surgical outcomes by illuminating cancer intraoperatively, potentially reducing recurrence and surgical sequelae in head and neck cancer patients.

Novel uPAR-Targeting Imaging Agent FG001 Shows Promise in Oral and Oropharyngeal Cancer Surgery

5 months ago

A phase II clinical trial demonstrates the efficacy of FG001, a novel uPAR-targeting near-infrared imaging agent, in the intraoperative detection of oral and oropharyngeal squamous cell carcinoma, achieving 100% sensitivity in tumor detection.

FluoGuide A/S Publishes Interim Report for the Period January - September 2024

6 months ago

FluoGuide A/S has released its interim report for the first nine months of 2024, highlighting preparations for the FG001 phase II head and neck trial application and progress on clinical and regulatory plans for aggressive brain cancer. The company reported a net loss of DKK 20,218 thousand for the period.

FluoGuide's FG001 Demonstrates Positive Phase 2 Data in Head and Neck Cancer Surgery

6 months ago

• FluoGuide's FG001, a novel imaging agent, has shown promising Phase 2 results in enhancing surgical accuracy for head and neck cancer patients. • The study, published in _Theranostics_, demonstrated 100% sensitivity in illuminating cancerous tissues with excellent tolerability across varying doses. • FG001 targets the uPAR receptor, potentially reducing local recurrence and surgical complications, thereby improving patient outcomes and lowering healthcare costs. • A new clinical trial is planned to start in Q1 next year, building on these findings to further evaluate FG001's efficacy in head and neck cancer surgery.

FluoGuide Submits Clinical Trial Application for Phase II Head and Neck Cancer Trial

8 months ago

• FluoGuide A/S has submitted a Clinical Trial Application (CTA) for a phase II trial of FG001 in head and neck cancer (oral squamous cell carcinoma). • The trial, designated CT-005, is a single-center study designed to evaluate multiple endpoints of FG001 in patients undergoing surgery. • Enrollment is planned for 25-30 patients, with the first patient expected in Q1 2025, and interim data anticipated in H2 2025. • The trial aims to optimize FG001's positioning for regulatory approval and commercialization, potentially leading to a multi-site registration trial.

FluoGuide Advances FG001 Development for Cancer Surgery Precision

a year ago

FluoGuide A/S updates on its strategy for FG001, a fluorescent molecule enhancing cancer surgery precision, with strong Phase II data in brain, head & neck, and lung cancers. Plans include a clinical trial for aggressive brain cancer registration by 2025 and exploring photothermal therapy's potential.

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

3 years ago

FluoGuide A/S has received approval from the Danish Medicines Agency to initiate a phase II trial for FG001 in head and neck cancer, aiming to improve surgical precision by illuminating cancer cells intraoperatively. The trial, set to begin in Q4 2022, will enroll up to 16 patients, with results expected in the first half of 2023.