FluoGuide announces positive top line result from the first part of the ongoing clinical phase I/II trial testing the safety and performance of FG001 in lightening up aggressive brain cancer
Copenhagen, Denmark, 01.04.2022 – FluoGuide A/S (“FluoGuide” or the “Company”) is pleased to announce that FG001 has been shown safe and well tolerated in 40 patients. The early evidence of efficacy has been demonstrated by strong illumination of brain tumors and histology data has now confirmed that the tissue lighted up is cancer. The optimal dose and time of FG001 administration has been decided to be 36 mg administered the evening before surgery.
In total, 40 patients have been administered and FG001 has been shown safe and well tolerated (please see table). 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.
| Overview of part 1 of phase I/II clinical trial | |||||||
| Cohort | Dosing | Dose (mg/pt) | Patients (#) | HGG *) (#) | Non-HGG/not completed (#) | Ligth in HGG (%) | |
| 1 | morning | 1 | 3 | 3 | 0 | 67% | |
| 2 | morning | 2 | 3 | 3 | 0 | 100% | |
| 3 | morning | 4 | 3 | 3 | 0 | 67% | |
| 4 | morning | 8 | 4 | 3 | 1 | 100% | |
| 5 | morning | 16 | 3 | 3 | 0 | 100% | |
| 5a | evening | 16 | 5 | 4 | 1 | 100% | |
| 6 | morning | 24 | 3 | 3 | 0 |
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| 7 | morning | 36 | 3 | 3 | 0 | 100% | |
| 7a | evening | 36 | 5 | 4 | 1 | 100% | |
| 8 | morning | 48 | 4 | 2 | 2 | 100% | |
| 8a | evening | 48 | 4 | 4 | 0 | 100% | |
| Total | 40 | 35 | 5 | NA | |||
| *) High Grade Glioma | |||||||
Four patients had other diagnoses than aggressive brain cancer (high grade glioma (‘HGG’)): One patient had a lung cancer metastasis (adenocarcinoma metastasis) in the brain, one patient had meningioma, and two patients had malignant melanoma metastases in the brain. Intriguingly, the patients with lung cancer metastasis and meningioma demonstrated good illumination of the cancers. One patient with HGG received FG001 but did not undergo surgery, and only safety was monitored.
The pharmacokinetic (PK) profile for FG001 was assessed for the eight 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, all patients revealed a clinically relevant TBR value.
The histology samples from dose cohort 7a (36 mg, evening) and dose cohort 8a (48 mg, evening) have been unblinded and analyzed. The histology results confirm that FG001 lights up aggressive brain cancer.
“Presenting good safety data for FG001 is universal for all indications and at the same time presenting the early evidence of efficacy in aggressive brain cancer is really encouraging for the patients, investors and our team” says Morten Albrechtsen and continues “We are very excited and are looking very much forward to evaluating FG001 in other cancer indications”.
A more detailed presentation of the clinical data will be presented orally at the 68th Scandinavian Neurosurgical Society (SNS) Congress to be held 14-16 May 2022 in Bergen, Norway.
The Company is currently elaborating the design of part 2 of the ongoing phase I/II trial together with clinicians from EU and US.
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 01-04-2022 12:29 CET.