FluoGuide has received green light to proceed to the next dose level with FG001 in the ongoing clinical phase I/II trial in patients undergoing surgical treatment of high grade glioma.
Copenhagen, Denmark, 18 May 2021 – FluoGuide A/S (“FluoGuide” or the “Company”) is pleased to announce that the dose escalation committee has reviewed the data from the fifth dose level and approved initiation of the next dose level. In addition, the company has received approval to commence with an evening dosing of the fifth dose level with FG001.
The results from the patients in the fifth dose level show, in line with the previous dose levels, that FG001 was well tolerated. The light intensity continues to increase with higher dose levels and light was detected in all patients.
FluoGuide can now in collaboration with the principal investigator chose to either increase the dose level with a morning administration or administer an already tested morning dose in the evening. The Company has decided to proceed with the fifth dose level in an evening administration.
Coming cohorts of patients will initially receive higher doses of FG001 in the morning to assess safety prior to being evaluated in an evening administration,
“The dosing in the evening will add important information and allow us to make an informed decision of the optimal dose to guide surgery in patients with high grade glioma undergoing surgery” says Morten Albrechtsen, CEO
It is important to underline that the first part of the trial must be completed and analyzed before any final conclusions on tolerability and safety profile can be made. It is also important to state that the pathology examination at the end of the first part is needed to confirm that the tissue that lights up is cancer and tissue that does not light up is free of cancer.
There is still a risk that the recruitment of patients over the next months may be slowed down due to the ongoing COVID-19 pandemic but FluoGuide expects to have data from the first part of the trial available within Q3 2021, also being the starting point to apply for new phase II clinical trials in other cancer indications, including a prevalent cancer such as lung or breast cancer.
This disclosure contains information that Fluoguide is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 18-05-2021 08:00 CET.
For further information, please contact:
Morten Albrechtsen, CEO
+45 24 25 62 66
Svensk Kapitalmarknadsgransking AB
Phone: +46 70 755 95 51
E-mail: [email protected]
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 conducting a proof-of-concept clinical study (phase I/II) to demonstrate the effect of FG001 in patients with high grade glioma. 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.
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