FG001 again demonstrates strong data in guiding glioblastoma surgery – accepted for presentation at the World Molecular Imaging Congress 2019

Mon, Aug 12, 2019 09:00 CET

FluoGuide A/S ("FluoGuide") today announces that new data confirms FG001’s potential in guiding surgical removal of glioblastoma. The data will be presented at the World Molecular Imaging Congress 2019 (WMIC) in Montreal, on September 4-7

FG001 is the first product from FluoGuide, which lights up the cancer and its invasive growth into the surrounding tissue. It helps the surgeon to remove the entire tumor during surgery and increases the chance for a complete cure of the patient. The task for the surgeon is simply to "turn the lights on and see the entire tumor". The solution helps surgeons to remove a minimal amount of normal tissue while at the same time reducing the risk of leaving behind cancer tissue. This reduces suffering for the patient and increases the likelihood of cure as well as reduces costs for the health care system.

FG001 will be injected into a vein of the patient prior to surgery and is currently prepared for a proof-of-concept clinical study where the first result is planned to be announced in first half of 2020.

The latest data on the FG001 technology and its use in Glioblastoma surgery has been selected for presentation at the World Molecular Imaging Congress 2019 (WMIC) in Montreal, to take place September 4-7, 2019. The presentation is entitled “Characterization of the uPAR targeting probe ICG-Glu-Glu-AE105 [FG001] in an orthotopic human xenograft glioblastoma model for optical guidance during surgery” and will be presented by PhD student Karina Juhl from Rigshospitalet and University of Copenhagen.

The preclinical study was conducted during the first half of 2019, with the aim of determining the optimal dosage and time window for use in surgery as a preparation for the human clinical study with FG001. The data repeated the earlier result, that FG001 was of great benefit in guiding surgical removal of glioblastoma with one injection before the start of surgery. The data also serves as a planning tool for designing the clinical study expected to start in 2020, with the first results to be communicated in the first half of 2020.

The World Molecular Imaging Congress (WMIC) is organized by the World Molecular Imaging Society (WMIS) and gathers widely recognized experts in molecular imaging. WMIC was established in 2011 by integrating the Academy of Molecular Imaging and the Society for Molecular Imaging into a single streamlined society focused on advancing the field of molecular imaging (MI). Within a relatively short time, the WMIS has significantly expanded its global footprint in this field by building and expanding upon existing strengths and infrastructures of these two organizations.

Andreas Kjær, in charge of research at FluoGuide, comments:

“We are happy to see another series of promising data now obtained with a product that has been produced under higher quality standards and closer to what will be used in the clinical trial in patients scheduled for next year. This will be an important milestone for the team that has been working hard on FG001 for years.”



For further information about FluoGuide, please contact:

Morten Albrechtsen, CEO

M: +45 24 25 62 66

ma@fluoguide.com

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About FluoGuide

FluoGuide A/S (Spotlight Stock Market: FLUO:SS) provides solutions for maximizing surgical outcome through intelligent targeting. FluoGuide’s first product FG001 increases precision in cancer surgery by lighting up the cancer and its invasive growth into the surrounding tissue. FG001 is expected to reduce suffering for the patients and increase the likelihood of cure. It can also reduce costs for the health care system for the benefit of society. FluoGuide focuses on demonstrating the effect of FG001 in patients by conducting a human proof-of-concept clinical trial and expects to announce the first result of this study during first half of 2020.

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