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(Alliance News) - IQ-AI Ltd shares fell on Wednesday, after it said its subsidiary Imaging Biometrics LLC is launching an intermediate population cohort expanded access programme for oral gallium maltolate.
Shares in the St Helier, Jersey-based medical services firm fell 5.6% to 4.20 pence each in London on Wednesday late morning.
Subject to US Food & Drug Administration approval, IQ-AI said the EAP will be for brain tumour patients located in the US who are unable to participate in the phase 1 clinical trial ongoing at the Medical College of Wisconsin.
The FDA's recent fast track designation for gallium maltolate serves as the motivation behind this launch, IQ-AI said.
To date, IQ-AI said oral gallium maltolate has exhibited an "excellent" safety profile and "promising" anti-tumour efficacy.
"Thus far, none of the patients that have participated in the phase 1 trial 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. Moreover, the agent can be taken from the comfort of their home," the company said.
Under an EAP, also referred to as "compassionate use", IQ-AI said the FDA works with companies to allow access to investigational products outside of a clinical trial.
IQ-AI said patients who have limited or no viable treatment alternatives can gain access to promising treatments, ahead of regulatory approval, in an attempt to fulfill an unmet clinical need.
"Along with providing immediate access to [gallium maltolate] for the potential benefit of some patients, the EAP will accelerate data obtained from a broader, real-world, patient population," said Chief Executive Officer Trevor Brown.
"This data would advance the development process on many levels including maximizing the full benefit of the fast track designation. Pending FDA approval, we expect the EAP to start in [the second quarter of 2024."
By Greg Rosenvinge, Alliance News senior reporter
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