Imaging Biometrics Ltd (LSE:IBAI, FRA:5Y1) said first-in-human Phase 1 results for oral gallium maltolate in recurrent glioblastoma support further clinical development, after the treatment was found to be well tolerated and given a recommended Phase 2 dose.
The company said the trial, published in the peer-reviewed journal Neuro-Oncology Advances, tested GaM in patients with recurrent or treatment-refractory glioblastoma at the Froedtert and Medical College of Wisconsin Clinical Cancer Center.
Investigators reported that oral GaM was safe and well tolerated at all dose levels up to 2,500 mg/day, with only Grade 1 or Grade 2 adverse effects and no Grade 3 or higher toxicities. No kidney toxicity was seen, which the company said was notable given historical renal risks linked to earlier gallium formulations.
The recommended Phase 2 dose was set at 2,000 mg/day. Among 22 patients evaluable for tumour response, median overall survival was 16 months and median progression-free survival was 2.5 months. Thirteen of the 22 patients survived for more than 12 months from the start of GaM treatment, while one patient achieved a partial response and remains on treatment after more than 38 months.
Chief executive Trevor Brown said the trial had established “a safe dosing regimen and a recommended Phase 2 dose”, while noting the study was not powered for efficacy. Imaging Biometrics said it now intends to reactivate its Expanded Access Programme to enrol up to 20 additional patients.
