Proactive Investors - IQ-AI Ltd (LON:IQAI) has announced that its wholly owned subsidiary Imaging Biometrics is launching an intermediate population cohort expanded access program (EAP) for oral gallium maltolate (GaM), subject to regulatory approval.
The EAP will be for brain tumour patients located throughout the US who are unable to participate in the ongoing phase-one clinical trial at the Medical College of Wisconsin.
Under an EAP (also referred to as ‘compassionate use’), the Food and Drug Administration (FDA) works with companies to allow access to investigational products outside of a clinical trial.
Patients who have limited or no viable treatment alternatives can gain access to promising treatments, ahead of regulatory approval, in an attempt to fulfil an unmet clinical need.
Oral GaM has exhibited an excellent safety profile and promising anti-tumour efficacy - no phase-one trial patients have reported dose-limiting toxicities.
On the contrary, patients have shared experiences of enhanced quality of life, allowing many patients to engage in normal, pre-diagnosis, activities.
Oral GaM can be taken from home, further enhancing the patients’ comfort.
Trevor Brown, chief executive of IQ-AI, commented: "Along with providing immediate access to GaM for the potential benefit of some patients, the EAP will accelerate data obtained from a broader, real-world, patient population.
“This data would advance the development process on many levels including maximising the full benefit of the Fast Track Designation.”
Brown expects the EAP to start in the second quarter, pending FDA approval.