“We are very pleased by these interim findings and the identification of the optimal FG001 dose,” says Donna Haire, Chief Operating Officer at FluoGuide. “Our collaboration with Professor Dr. Max Witjes, a leading international expert in fluorescence-guided margin assessment in head and neck cancer surgery, and his clinical team is bringing us closer to our goal of giving surgeons real-time margin information to guide decisions during surgery.”

FG001 

FG001 is FluoGuide’s most advanced development program. It is designed to bind selectively to cancerous tissue and light it up, helping surgeons remove more cancer with greater precision while sparing healthy tissue. FG001 is being developed as a surgical guidance adjuvant across multiple cancer indications, with a focus on high-grade glioma and oral head and neck cancers. In the United States, FG001 has received Orphan Drug designation and FDA Fast Track designation for high-grade glioma. FluoGuide has also completed a successful IND submission, with FDA authorization to initiate a U.S. high-grade glioma Phase 2 clinical trial expected to support registration.

FG001-CT-005 

FG001-CT-005 is an open-label, single-dose, dose-finding exploratory Phase 2 trial evaluating FG001, an optical imaging agent, in patients with oral squamous cell carcinoma. The trial is designed to support intraoperative visualization of inadequate surgical margins, with the goal of helping surgeons assess and address inadequate margins while the patient is still in the operating room, rather than waiting for postoperative pathology results.

The primary endpoint of FG001-CT-005 is assessment of the optimal FG001 dose and administration timing. FG001-CT-005 is divided into two parts: Part 1, a dose-finding phase involving 15 patients, and Part 2, a dose-timing phase involving an additional 10 patients. The results reported herein are from Part 1, the dose-finding phase.

The results are from the 15 evaluable patients in the dose-finding part of the trial, in which FG001 doses of 0.15, 0.30, and 0.45 mg/kg were administered 14–18 hours prior to surgery. Based on this analysis, FluoGuide identified 0.30 mg/kg as the optimal FG001 dose, meeting the trial’s primary endpoint.

FG001 was confirmed to be very well tolerated, consistent with the safety profile observed in more than 125 patients treated with FG001 across clinical studies to date.

“The positive Part 1 results strengthen our vision that FG001, in collaboration with surgeons and imaging system manufacturers, has the potential to support an integrated surgical workflow that bring timely margin assessment into the operating room for oral head and neck cancer surgery, with the goal of providing a major benefit to patients,” says Morten Albrechtsen, CEO, “While additional data remain to be analyzed, we are encouraged that the findings to date support the key clinical objective of providing surgeons with margin information early enough to guide further resection.”