IQ-AI Limited (LON:IQAI) is to finance a phase 1 study to evaluate the safety and efficacy of Gallium Maltolate in the treatment of brain tumours.
If the trial is successful IQAI intends to apply to the US Food and Drug Administration (FDA) for orphan drug status under the FDA's orphan drug designation programme, which grants market exclusivity in the US for seven years following approval of the drug.
Recent pre-clinical animal studies have shown that Gallium Maltolate can significantly reduce the size of tumours within 10 days of treatment, so IQ-AI is keen to try the treatment out on humans as soon as possible.
To this end, an investigational new drug application has been submitted to the FDA pending approval of a phase 1 trial scheduled to begin this summer. The trial is being conducted at the Medical College of Wisconsin (MCW) Cancer Center and is designed primarily to determine the optimal dose that can be administered safely to patients. During the two-year study, investigators will closely monitor the efficacy of Gallium Maltolate in GBM patients suffering from glioblastoma (GBM), a grade IV brain tumour.
While efficacy is not the primary aim of a phase 1 trial, the investigators will monitor the size of the tumour using magnetic resonance imaging throughout the course of the trial. Given the aggressive growth of GBM, it is possible that the investigators could obtain an early indication of the efficacy of the treatment during the trial, IQ-AI said.
“Current treatment protocols for GBM have done little to reduce mortality. The pre-clinical trial produced promising results, but we cannot know whether these results are replicable in humans until clinical trials are completed," said Trevor Brown, the chief executive officer of IQAI.
Shares in IQ-AI were up 4.4% at 8.25p in early deals.