An open-label, single dose, dose finding, exploratory phase II trial of FG001 (an optical imaging agent) for intraoperative visualization of inadequate margins in subjects with oral squamous cell carcinoma.

Start Date14 Apr 2025

Sponsor / Collaborator

FluoGuide A/S

NCT06684795

/ RecruitingPhase 2IIT

An Open-label, Non-randomized, Single Dose, Phase II Trial of FG001 (an Optical Imaging Agent) for Localization of Meningiomas or Presumed Low-Grade Gliomas Scheduled for Neurosurgery

In neurosurgery both the diffusely infiltrated gliomas of the brain as well as the border towards healthy tissue in the meninges is a challenge. For the high-grade contrast enhanced gliomas fluorescent drugs like Gliolan have been used in several years and proved its clinical value. For non-contrast enhanced gliomas, like low-grade glioma, no such drug exist. The transition zone towards healthy non-tumor cell infiltrated brain in such low-grade gliomas is extremely difficult but for these patients their prognosis depends on the amount of non-healthy tissue left behind. Also, in benign tumors as meningioma the complete resection including infiltrated meninges is of importance for the cure of the disease. None of the existing fluorescent drug is useful or approved for these tumors.. Hence a medicinal product that will fulfil the criteria for a safe and reliable fluorescent drug to guide the surgery to the boundaries of the infiltration with tumor cells is highly warranted.

Start Date01 May 2024

Sponsor / Collaborator

Rigshospitalet

EUCTR2023-000163-31-DK

/ Unknown statusPhase 2IIT

An open-label, non-randomized, single dose, phase II trial of FG001 (an optical imaging agent) for localization of Meningiomas or presumed Low-Grade Gliomas scheduled for neurosurgery

Start Date27 Mar 2023

Sponsor / Collaborator

Copenhagen University Hospital

100 Clinical Results associated with FG-001

100 Translational Medicine associated with FG-001

100 Patents (Medical) associated with FG-001

Literatures (Medical) associated with FG-001

01 Jan 2025·Theranostics

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

Article

Author: Kiss, Katalin ; Kjaer, Andreas ; von Buchwald, Christian ; Straede, Karina ; Poulsen, Anne ; Rubek, Nicklas ; Lawaetz, Mads ; Hahn, Christoffer Holst ; Lelkaitis, Giedrius ; Christensen, Anders ; Paaske, Natasja ; Andersen, Amanda Oester ; Wessel, Irene

Background: In oral and oropharyngeal squamous cell carcinoma (OSCC, OPSCC), frequent inadequate surgical margins highlight the importance of precise intraoperative identification and delineation of cancerous tissue for improving patient outcomes. Methods: A prospective, open-label, single-center, single dose, exploratory phase II clinical trial (EudraCT 2022-001361-12) to assess the efficacy of the novel uPAR-targeting near-infrared imaging agent, FG001, for intraoperative detection of OSCC and OPSCC. Macroscopic tumor detection was quantified with sensitivity and intraoperative tumor-to-background ratio (TBR). Microscopic tumor-specificity was assessed by analysis of morphological co-localization between tumor tissue, uPAR-expression, and optical signal. Blood samples were collected up to 44 hours post-injection to further characterize the pharmacokinetic profile of the agent. The trial was conducted with close safety monitoring. Results: Sixteen patients undergoing primary surgical resection were systemically administered 36 mg (n = 4), 16 mg (n = 8), or 4 mg (n = 4) of FG001 the evening prior to surgery. Intraoperatively, using a near-infrared imaging system, real-time optical imaging successfully identified all 16 tumors (sensitivity: 100%, mean TBR: 2.99 range: 2.02 - 3.95), and tumor-specificity was confirmed by histology. Clinical neck metastasis was detected with optical imaging. The maximal plasma concentrations were measured after 1 hour, and the half-life of FG001 was 12 hours. No drug-related or serious adverse events were observed. Conclusions: FG001 holds great potential for optical molecular imaging of OSCC and OPSCC. Further trials are warranted to explore FG001 for intraoperative margin delineation and as a decision-making tool.

01 Jan 2022·Acta neurochirurgicaQ3 · MEDICINE

A new uPAR-targeting fluorescent probe for optical guided intracranial surgery in resection of a meningioma—a case report

Q3 · MEDICINE

Article

Author: Skjøth-Rasmussen, Jane ; Larsen, Carl Christian ; Scheie, David ; Azam, Aleena ; Juhl, Karina ; Kjaer, Andreas

Meningiomas are benign lesion although anot insignificant number experiences recurrences despite Simpson grade 1 removal. FG001 is a compound with a fluorophore (ICG) that binds to a urokinase-type plasminogen activator receptor (uPAR) and is currently investigated at our institution in a first-in-human trial. The patient presented with a plausible malignant glioma but proved to be a grade 1 meningioma. FG001 could delineated the tumor not only on the surface but supplementary in the cavity to remove safely the dural attachment. We present FG001 as a new promising tool for improved surgical radicality beyond the intended indication, provided that a prospective validation in a consecutive meningioma cohort demonstrates similar results.

News (Medical) associated with FG-001

15 Apr 2025

·fluoguide.com

FluoGuide includes first patient in phase II trial of FG001 for head and neck cancer

The trial is conducted in collaboration with the University Medical Center Groningen and is led by Principal Investigator Prof. Dr. Max Witjes. It aims to evaluate the effectiveness of FG001, a novel optical imaging agent that light up cancerous tissue to improve surgical precision in patients undergoing surgery for oral squamous cell carcinoma, a type of head and neck cancer. By improving tumor visibility, FG001 helps surgeons achieve more complete removal of the cancerous tissue while preserving healthy tissue. The trial will also explore the use of different types of surgical equipment to access FG001’ application across a variety of surgical environments. “Initiation of this trial marks a significant milestone in our mission to enhance surgical outcomes for patients with head and neck cancer, also reflecting the strong collaboration between FluoGuide, leading surgeons, and surgical equipment partners, including Intuitive Surgical to address the challenges posed by cancerous tumors located in anatomically complex areas.” says Morten Albrechtsen, CEO of FluoGuide, “We look forward to advance FG001 through this trial and look forward to the interim data, which will be a key step forward in the development of our head and neck program for FG001.” The trial is a single-center trial (FG001-CT-005) designed to: Evaluate multiple endpoints for measuring surgical completeness using FG001 Explore the different benefits of FG001 in assisting head and neck cancer surgery Assess the use of different surgical equipment types The first interim date is anticipated in the second half of 2025 and will serve as a key data trigger point. Upon completion of this phase II trial and guided by data, FluoGuide plans to initiate a multi-site registration trial as the next step toward regulatory approval and commercialization of FG001.

Phase 2

27 Feb 2025

·fluoguide.com

FluoGuide A/S publishes interim report for the period January – December 2024

In the fourth quarter, the Company submitted a clinical trial application for the FG001 phase II head and neck trial application (CT-005). This milestone reflects extensive planning based on positive results from the earlier FG001 trial (CT-003), published in Theranostics, which showed successful cancer detection in all 16 patients. FluoGuide had no revenue for the period 1 October to 31 December 2024 and posted a net loss of DKK 8,741 thousand (DKK 12,387 thousand) for the period. FluoGuide had no revenue for the period 1 January to 31 December 2024 and posted a net loss of DKK 28,959 thousand (DKK 38,377 thousand) for the period. The total number of shares as of September 30, 2024, amounted to 13,620,149 shares. The total number of shares as of September 30, 2023, amounted to 11,814,500 shares. The average number of shares in Q3 2024 amounted to 13,620,149 shares as no issuance of new shares have taken place. Figures in ‘()’ refer to the same period last year. Highlights during Q4: FluoGuide submits Clinical Trial Application for phase II trial in head and neck cancer (CT-005) Publication of positive phase II clinical data for FG001 in patients with head and neck cancer (CT-003) Highlights after Q4: FluoGuide receives approval of CTA for phase II trial in head and neck cancer (CT-005) "2024 was a pivotal year for FluoGuide, marked by a new strategic partnership, advancements in FG001’s therapeutic potential and successful capital raise." says Morten Albrechtsen CEO at FluoGuide.

Phase 2Financial StatementClinical Trial FailureClinical Result

27 Feb 2025

·fluoguide.com

FluoGuide A/S publishes year-end and annual report for the fiscal year 2024

FINANCIAL HIGHLIGHTS 2024 HIGHLIGHTS Q1 2024 Entered a strategic collaboration with Intuitive Surgical, focusing on integrating FG001 into robotic-assisted surgery for head and neck cancer. Provided a strategic update outlining development plans for FG001 towards commercialization. Q2 2024 Successfully raised SEK 60 million through a directed share issue, strengthening the financial foundation for ongoing clinical development. Selected a laser system for photothermal therapy with FG001, advancing its dual capability as both a surgical guidance and therapeutic tool. Q3 2024 Appointed Jens Ellrich as Chief Medical Officer, bringing critical expertise in clinical development and regulatory strategy. Submitted a Clinical Trial Application (CTA) for FG001 in head and neck cancer, progressing towards regulatory approval. Q4 2024 Published positive Phase II data for FG001 in head and neck cancer, validating its ability to improve surgical precision and outcomes. Progressed FG001 trials in aggressive brain cancer and additional indications such as meningioma and low-grade glioma, with results expected in 2025. Strengthened leadership and governance through key appointments and board adjustments. Highlights after the period: The Company received approval for phase II trial in head and neck cancer. “2024 was a pivotal year for FluoGuide, marked by a new strategic partnership, advancements in FG001’s therapeutic potential and successful capital raise” says Morten Albrechtsen, CEO. LOOKING AHEAD – 2025 MILESTONES Advance FG001 toward FDA consultations to confirm the design of the registration trial in aggressive brain cancer. Enroll the first patient in the Phase II trial (FG001-CT-005) for FG001 in head and neck cancer. Deliver interim data from the head and neck cancer trial (FG001-CT-005) to guide regulatory progress. Expand FG001’s applications in photothermal therapy and brain cancer indications. Establish new strategic partnerships to accelerate FG001’s commercialization. PRESENTATION In connection with the annual report publication, CEO Morten Albrechtsen and CFO Ole Larsen will participate in an interview with Redeye analyst Christian Binder on February 27, 2025. The interview will be video-recorded and uploaded to FluoGuide’s website under Investor Presentations on February 28, 2025.

Phase 2Clinical ResultExecutive ChangeFinancial Statement

100 Deals associated with FG-001

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Head and Neck Neoplasms	Phase 2	Denmark	FluoGuide A/S	30 Jan 2022
High grade glioma	Phase 2	Denmark	FluoGuide A/S	30 Jan 2022
Non-Small Cell Lung Cancer	Phase 2	Denmark	FluoGuide A/S	30 Jan 2022

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


FG001-CT-001 (Corporate Publications) Manual	Phase 2	High grade glioma	24	FG001	egshgvdylt(onqeyalxkh) = qruvsumnot dzncvvzwyi (lfyrkeslmc ) Met View more	Positive	13 Nov 2023
FG001-CT-001 (Corporate Publications) Manual	Phase 2	High grade glioma	24	5-ALA	egshgvdylt(onqeyalxkh) = maoukywppp dzncvvzwyi (lfyrkeslmc ) Met	Positive	13 Nov 2023
PipelineReview Manual	Phase 2	Head and Neck Neoplasms	16	FG001	cpexkoiyvz(qyqnejqorv) = xfpxiocfkp mzpwglxvfh (xsnchqbdcg )	Positive	06 Nov 2023

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