FLUOGUIDE A/S 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 |
| |
| 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
A more detailed presentation of the clinical data will be presented orally at the 68th
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
For further information, please contact:
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About
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
https://news.cision.com/fluoguide/r/fluoguide-announces-positive-top-line-result-from-the-first-part-of-the-ongoing-clinical-phase-i-ii-,c3538026
https://mb.cision.com/Main/18164/3538026/1558138.pdf
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