Publication of Phase 1 Clinical Trial

Imaging Biometrics Limited

09 June 2026

 

Imaging Biometrics Limited

("Company")

9 June 2026

Publication of Phase 1 Clinical Trial of Oral Gallium Maltolate (GaM) in Recurrent Glioblastoma and Reopening of Expanded Access Programme

Imaging Biometrics Limited (LSE: IBAI) announces the publication in the peer-reviewed journal Neuro-Oncology Advances describing the results from the Phase 1 clinical trial (NCT04319276) of oral gallium maltolate in patients with recurrent or treatment-refractory glioblastoma (GBM). Imaging Biometrics, LLC, a wholly owned subsidiary of Imaging Biometrics Limited, was the primary sponsor of the trial. This marks the first in-human study results of GaM for glioblastoma. The trial, conducted at the Froedtert and Medical College of Wisconsin Clinical Cancer Center, demonstrated that oral GaM was well tolerated and showed preliminary signals of survival benefit, supporting further clinical development.

Summary of published results

The trial was a dose-escalation study designed primarily to assess safety and to establish a recommended Phase 2 dose (RP2D). Key findings reported by the investigators were:

•     Oral gallium maltolate was safe and well tolerated at all dose levels up to 2,500 mg/day. Only Grade 1 or Grade 2 adverse effects were observed, with no Grade 3 or higher toxicities. No kidney toxicity was seen. The absence of nephrotoxicity is particularly notable given historical renal risks associated with earlier gallium formulations and supports the feasibility of chronic oral administration in patients with recurrent glioblastoma.

•     The recommended Phase 2 dose (RP2D) was determined to be 2,000 mg/day.

•     Among the 22 patients evaluable for tumour response, the investigators reported a median overall survival of 16 months and a median progression-free survival of 2.5 months. The authors note that the median overall survival compares favourably with the range of 5.5 to 12.6 months reported in a published meta-analysis of treatments for recurrent GBM, while emphasising that no conclusions on efficacy can be drawn from a Phase 1 study of this design.

•     Of note, 13 of 22 patients achieved a survival, measured from start of treatment with GaM, of greater than 12 months. One patient achieved a partial response and remains on treatment after more than 38 months.

The authors conclude that further investigation of the clinical efficacy of gallium maltolate in GBM is warranted, and that this will require a statistically powered, Phase 2 trial.

Regulatory status

Gallium maltolate holds Fast Track, two Orphan Drug and two Rare Pediatric Disease designations from the U.S. Food and Drug Administration (FDA). These designations relate to the regulatory development pathway and do not constitute any determination of efficacy by the FDA.

Reopening of the Expanded Access Programme

In response to continued interest from patients and clinicians, Imaging Biometrics intends to reactivate its Expanded Access Programme (EAP) to enrol up to 20 additional patients. The EAP provides a route for eligible patients to access investigational gallium maltolate outside of a clinical trial. As an investigational agent, GaM has not been approved by any regulatory authority; its safety and efficacy have not been established. Decisions regarding suitability for the EAP are a matter for a patient's treating physician.

Comment

Trevor Brown, Chief Executive Officer of Imaging Biometrics Ltd, commented:

"We are encouraged that this trial has established a safe dosing regimen and a recommended Phase 2 dose for oral gallium maltolate. Although the study was not powered for efficacy, the results provide encouraging evidence of biological and clinical activity, including durable disease stabilization and prolonged survival in select patients. We are grateful to the patients and clinical investigators who made it possible. Glioblastoma remains an area of profound unmet need."

For further information, please contact:

Imaging Biometrics Limited

Trevor Brown / Brett Skelly / Michael Schmainda / John Richardson

Tel: [phone]

AlbR Capital Limited

Corporate Broker

Lucy Williams / Duncan Vasey

Tel: [phone]

 

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