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.

开始日期2024-05-01

申办/合作机构

Rigshospitalet

EUCTR2023-000163-31-DK

/ Unknown status临床2期IIT

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

开始日期2023-03-27

申办/合作机构

Copenhagen University Hospital

EUCTR2022-001361-12-DK

/ Not yet recruiting临床2期

An open-label, non-randomized, single center, single dose, exploratory phase II trial of FG001 (an imaging agent) for localization of oral and oropharyngeal squamous cell carcinoma

开始日期2022-08-25

申办/合作机构

FluoGuide A/S

100 项与 FG-001 相关的临床结果

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100 项与 FG-001 相关的转化医学

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100 项与 FG-001 相关的专利（医药）

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项与 FG-001 相关的文献（医药）

2025-01-01·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

作者: 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.

2022-01-01·Acta neurochirurgica3区 · 医学

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

3区 · 医学

Article

作者: 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.

项与 FG-001 相关的新闻（医药）

2025-01-15

·fluoguide.com

FluoGuide A/S receives approval for phase II trial in head and neck cancer

The Phase II Clinical Trial Application (CTA) for FG001 in head and neck cancer, announced on October 7, 2024, has been granted approval under the new European process by the Dutch Central Committee on Research Involving Human Subjects and the Medical Ethical Committee of the University Medical Center Groningen. The CTA submission followed strong clinical topline data from a proof-of-concept Phase II clinical trial of FG001 in patients with head and neck cancer. The trial evaluated surgical precision using various surgical equipment and advanced FG001 to help patients with head and neck cancer.” Morten Albrechtsen, CEO at FluoGuide states: "The approval is a significant milestone to advance FG001 helping patients with head and neck cancer. We are on track to enroll first patient in first quarter of 2025 and the key data trigger point is expected in the second half of 2025 with the interim data.” FluoGuide and Principal Investigator Prof. Dr. Max Witjes are now preparing to initiate the Phase II trial (CT-005) in head and neck cancer, which will be conduct a single center trial to: Evaluate multiple endpoints for measuring surgical completeness with FG001 in patients with head and neck cancer Explore different benefits of FG001 in assisting these patients Access the use of various surgical equipment types Enroll 25-30 patients, with enrollment starting in Q1 2025 The interim data is expected in the second half of 2025 being the data trigger point The trial completing in H2 2026 Depending on trial data and regulatory feedback, the FluoGuide plans to conduct a multisite registration trial as the next step toward approval and commercialization.

临床2期临床申请

2025-01-15

·access wire

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

KØBENHAVN, DK / ACCESSWIRE / January 15, 2025 / FluoGuide A/S (STO:FLUO) Copenhagen, Denmark - FluoGuide A/S (\"FluoGuide\" or the \"Company\"), a biotech company specializing in precision cancer surgery, announces approval of its phase II Clinical Trial Application for FG001 in head and neck cancer (oral squamous cell carcinoma cancer).The Phase II Clinical Trial Application (CTA) for FG001 in head and neck cancer, announced on October 7, 2024, has been granted approval under the new European process by the Dutch Central Committee on Research Involving Human Subjects and the Medical Ethical Committee of the University Medical Center Groningen.The CTA submission followed strong clinical topline data from a proof-of-concept Phase II clinical trial of FG001 in patients with head and neck cancer. The trial evaluated surgical precision using various surgical equipment and advanced FG001 to help patients with head and neck cancer.\"Morten Albrechtsen, CEO at FluoGuide states: \"The approval is a significant milestone to advance FG001 helping patients with head and neck cancer. We are on track to enroll first patient in first quarter of 2025 and the key data trigger point is expected in the second half of 2025 with the interim data.\"FluoGuide and Principal Investigator Prof. Dr. Max Witjes are now preparing to initiate the Phase II trial (CT-005) in head and neck cancer, which will be conduct a single center trial to:Evaluate multiple endpoints for measuring surgical completeness with FG001 in patients with head and neck cancerExplore different benefits of FG001 in assisting these patientsAccess the use of various surgical equipment typesEnroll 25-30 patients, with enrollment starting in Q1 2025The interim data is expected in the second half of 2025 being the data trigger pointThe trial completing in H2 2026Depending on trial data and regulatory feedback, the FluoGuide plans to conduct a multisite registration trial as the next step toward approval and commercialization.For further information, please contact:Morten Albrechtsen, CEOFluoGuide A/SPhone: +45 24 25 62 66E-mail: [email protected]Certified Adviser:Svensk Kapitalmarknadsgransking ABWebsite: www.skmg.seAbout FluoGuideFluoGuide takes precision surgery to the next level improving the outcome for cancer patients. The Company\'s lead product, FG001, is designed to improve surgical precision by illuminating cancer intraoperatively. This improved precision enabled by FluoGuide\'s products is expected to have a dual benefit - it reduces both the frequency of local recurrence post-surgery and lessens surgical sequelae. This improved precision will increase a patient\'s chance of achieving a complete cure and will lower system-wide healthcare costs. FG001 binds to the receptor uPAR being extensively expressed on most solid cancer types. The photothermal potential of FG001 could add a direct treatment effect of FG001 to further benefit for patients with cancer undergoing surgery.The Company has published strong results from phase II trials demonstrating the efficacy of FG001 as well as showing it was well tolerated and safe from clinical trials in patients undergoing surgery to remove aggressive brain (high-grade glioma), head & neck and lung cancers. Based on this strong foundation, FluoGuide expands the scope of application of FG001 and advances the development toward approval in aggressive brain cancer.FluoGuide is listed on Nasdaq First North Growth Market, Stockholm under the ticker \"FLUO\". Read more about FluoGuide\'s pipeline, technology, and upcoming events on www.fluoguide.comAttachmentsFluoGuide A/S receives approval for phase II trial in head and neck cancerSOURCE: FluoGuide A/SRelated Documents:

临床2期临床结果

2024-11-27

·access wire

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

KØBENHAVN, DK / ACCESSWIRE / November 27, 2024 / FluoGuide A/S (STO:FLUO) Copenhagen, Denmark, 27 November 2024 - Fluoguide A/S ("FluoGuide" or the "Company") today releases its results for the period 1 January 2024 - 30 September 2024. The Q3 report is available as attached document to this press release and on FluoGuide's website.In the third quarter, preparations for the FG001 phase II head and neck trial application (CT-005) were made, informed by feedback from global key opinion leaders about patient needs and trial design. 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. Progress is also being made on clinical and regulatory plans for aggressive brain cancer, with updates expected in the first half of next year.FluoGuide had no revenue for the period and posted a net loss of DKK 5,495 thousand (net loss of DKK 9,315 thousand) for the period July 1 to September 30, 2024. For the period January 1 - September 30, 2024, FluoGuide posted a net loss for the period of DKK 20,218 thousand (net loss of DKK 25,990 thousand).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.KEY FIGURESQ3 24Q3 23YTD 2024YTD 20232023DKK thousand1-Jul-241-Jul-231-Jan-241-Jan-231-Jan-23 30-Sep-2430-Sep-2330-Sep-2430-Sep-2331-Dec-23Net Revenue00000Income before interest and tax (EBIT)-6,532-10,862-22,993-31,164-43,924Net result for the period-5,495-9,315-20,218-25,990-38,377Cash and bank20,1578,94520,1578,94521,668 Solvency ratio (%)90%73%90%73%43%Result per share (DKK)-0.40-0.78-1.59-2.16-3.22Figures in ‘()' refer to the same period last year.Highlights during Q3:FluoGuide appoints Jens Ellrich as Chief Medical OfficerHighlights after Q3: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)"Submission of the clinical trial application for head and neck cancer marks an important milestone building on the positive interim results for FG001. This represents the culmination of extensive planning moving FG001 toward approval" , says Jens Ellrich, CMO at FluoGuide.Q3 Company updates and presentations:Interview releaseInterview with: Redeye analyst, Christian Binder and for FluoGuide CEO Morten Albrechtsen and CFO Ole LarsenRelease date: Wednesday, 27 NovemberQuestions are welcome to [email protected] before Wednesday, 27 November at 10:30 CETCertified Adviser:Svensk Kapitalmarknadsgransking ABPhone: +46 70 755 95 51E-mail: [email protected]For further information, please contact:Morten Albrechtsen, CEOFluoGuide A/SPhone: +45 24 25 62 66E-mail: [email protected]About FluoGuideFluoGuide is a biotech company specializing in precision cancer surgery. FluoGuide's lead product, FG001, is designed to enhance surgical accuracy by illuminating cancer cells intraoperatively using fluorescent light, which binds to the uPAR receptor, widely expressed in most solid cancer types. It is anticipated that FG001 will decrease both the incidence of local recurrence after surgery and surgical complications, improving cancer treatment and outcomes for patients, while also reducing healthcare costs. Moreover, FluoGuide's technology platform may also be utilized for photothermal therapy (PTT), which kills cancer cells through heating them with the use of near-infrared light. A technique that spares healthy surrounding tissue from damage, offering a direct therapeutic effect of FG001, further benefiting patients undergoing cancer surgery.FluoGuide is listed on the Nasdaq First North Growth Market in Stockholm under the ticker symbol "FLUO". For more information about FluoGuide's pipeline, technology, and upcoming events, visit www.fluoguide.comAttachmentsQ3 2024 FvSOURCE: FluoGuide A/S

临床2期财报高管变更临床结果

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适应症	最高研发状态	国家/地区	公司	日期
头颈部肿瘤	临床2期	丹麦	FluoGuide A/S	2022-01-30
高级别胶质瘤	临床2期	丹麦	FluoGuide A/S	2022-01-30
非小细胞肺癌	临床2期	丹麦	FluoGuide A/S	2022-01-30

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


FG001-CT-001 (Corporate Publications) 人工标引	临床2期	高级别胶质瘤	24	FG001	製構鏇醖願鬱醖窪淵範(醖獵膚襯醖積鏇構鹽淵) = 範選鹹簾糧齋築夢顧構觸選積醖顧齋鬱築膚願 (製顧繭構簾壓構鹽襯簾 ) 达到更多	积极	2023-11-13
FG001-CT-001 (Corporate Publications) 人工标引	临床2期	高级别胶质瘤	24	5-ALA	製構鏇醖願鬱醖窪淵範(醖獵膚襯醖積鏇構鹽淵) = 繭鹹艱網艱憲餘窪淵願觸選積醖顧齋鬱築膚願 (製顧繭構簾壓構鹽襯簾 ) 达到	积极	2023-11-13
PipelineReview 人工标引	临床2期	头颈部肿瘤	16	FG001	鑰糧壓襯膚齋憲夢選廠(糧遞淵築積簾願廠願憲) = 艱窪繭醖醖構艱觸製獵構範憲網構廠簾壓鹽窪 (餘膚製製獵製獵夢鏇糧 )	积极	2023-11-06