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FluoGuide invites to presentation of FG001 results from the first clinical trial in aggressive brain cancer on 17 May 2022

Press release


May 6, 2022

Copenhagen, Denmark, 6 May 2022 – FluoGuide A/S (“FluoGuide” or the “Company”) invites to a presentation of the results from the clinical trial of FG001 used to guide surgery in patients with aggressive high-grade glioma brain cancer, which will first be presented at the 68th Scandinavian Neurosurgical Society (SNS) Congress held 14-16 May 2022, in Bergen, Norway

As a follow-up on the presentation done by Principal Investigator and Chief Surgeon Jane Skjøth-Rasmussen in Bergen, FluoGuide hereby invites to an online presentation of the same data that will be presented at the SNS congress. The online presentation with subsequent discussion, will be held on 17 May at 2.00 pm CEST.

The agenda is as followed:
Welcome by Morten Albrechtsen, CEO.
Presentation by Principal Investigator, Chief surgeon Jane Skjøth-Rasmussen, MD, PhD
Open up for Q&A
Future clinical trials in brain cancer by Morten Albrechtsen, CEO
Closing remarks by Morten Albrechtsen, CEO

Together with Principal Investigator, Chief Surgeon Jane Skjøth-Rasmussen, PhD (Rigshospitalet), Andreas Kjær, Professor and CMO, and Morten Albrechtsen, CEO will also participate in the presentation and discussion.

To register for the online presentation, please register at: www.ir.live/fluoguide
To call in via phone, please, use the following details:
Attendee Dial-in Number: +1 (312) 248-9348
Attendee Dial-in ID Number: 536473
Attendee Dial-in Passcode: 9585

Resume of the trial:
In total, 40 patients have been administered FG001 that has been shown to be safe and well-tolerated. No serious drug related adverse events have been reported. Only a few drug-related adverse events were reported as grades 1 or 2, and no pattern or dose relation was observed

The pharmacokinetic (PK) profile for FG001 was assessed for all dose levels. FG001 showed dose-dependent increases in exposure across dose levels in a linear manner.

Tumor-to-background ratio (TBR) is a measure of the contrast. At the optimal dose and time, 36 mg administered the evening before the surgery, all patients revealed a clinically relevant TBR value.

The histology samples from dose 36 mg, evening, and dose 48 mg, evening, have been unblinded and analyzed. The histology results confirm that FG001 lights up aggressive brain cancer.

For further information, please contact:
Morten Albrechtsen, CEO
FluoGuide A/S
+45 24 25 62 66
ma@fluoguide.com

Certified Adviser:
Svensk Kapitalmarknadsgransking AB
Phone: +46 70 755 95 51
E-mail: ca@skmg.se

About FluoGuide
FluoGuide’s primary focus is to maximize surgical outcomes in oncology. The Company’s lead product, FG001, is designed to improve surgical precision by illuminating cancer cells intraoperatively. The improved precision enabled by FluoGuide’s products has a dual benefit – it reduces both the frequency of local recurrence post-surgery and lessens surgical sequelae. Ultimately, the improved precision will improve a patient’s chance of achieving a complete cure and will lower system-wide healthcare costs. The Company is has demonstrated efficacy of F001 as well as it to be well tolerated and safe in the ongoing proof-of-concept clinical study (phase I/II) in patients with high grade glioma undergoing surgery. FluoGuide has also started a phase II trial to demonstrate the effect of FG001 in guiding cancer surgery in patients with lung cancer. FluoGuide is listed on Nasdaq First North Sweden under the ticker “FLUO”.

About high grade glioma and glioblastoma
The first indication for FG001 is glioblastoma but FG001 has potential in several indications. Almost all patients with glioblastoma have a cancer expressing uPAR. A total of 60,000 patients gets high grade glioma and more than 30.000 patients are diagnosed with glioblastoma annually in the EU and US. Approximately 8-12 % of the patients are children. The prognosis for individuals with glioblastoma is very poor. Approximately 50 % of the patients die within 14 months and only 5 % are alive after five years from diagnosis. Precise removal of glioblastoma tumors is very difficult due the brain contains vital structures often near the cancer. Local reoccurrence of glioblastoma is common and happens in almost 100% of all patients.

This project has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No 954904.