Imaging Biometrics (LSE:IBAI) (LSE: IBAI) published peer-reviewed Phase 1 results showing oral gallium maltolate was well tolerated at doses up to 2,500 mg/day, yielded a recommended Phase 2 dose of 2,000 mg/day and produced preliminary signals of survival benefit in recurrent glioblastoma.
The study, sponsored by Imaging Biometrics' US subsidiary and conducted at the Froedtert and Medical College of Wisconsin Clinical Cancer Center as the first in‑human trial, reported a median overall survival of 16 months and a median progression-free survival of 2.5 months among 22 evaluable patients, with 13 patients surviving more than 12 months and one ongoing partial response beyond 38 months.
"We are encouraged that this trial has established a safe dosing regimen and a recommended Phase 2 dose for oral gallium maltolate," Trevor Brown, Chief Executive Officer of Imaging Biometrics, said.
Gallium maltolate holds Fast Track, two Orphan Drug and two Rare Pediatric Disease designations from the US Food and Drug Administration.
Imaging Biometrics said it intends to reactivate its Expanded Access Programme to enrol up to 20 additional patients to provide access to the unapproved investigational agent outside a clinical trial.
The authors and the company state that a statistically powered Phase 2 trial will be required to determine clinical efficacy.
