IB Announces Expanded Access Program for GaM

Imaging Biometrics, LLC (IB), a wholly owned subsidiary of IQ-AI Ltd (LSE: IQAI), has received FDA approval to proceed with an Expanded Access Program (EAP) for its lead therapeutic candidate, gallium maltolate (GaM). The EAP is for adult patients with recurrent/refractory glioblastoma who meet certain program eligibility criteria.

EAPs are regulated by the Food and Drug Administration (FDA) and allow patients who are otherwise not eligible for clinical trials to have access to potential therapies ahead of regulatory approval. In the case of a serious condition or life-threatening disease for which there are no viable treatment options, and where a clinical trial is not an option for a patient, a doctor can prescribe an unapproved therapy through an FDA EAP.

"Considering the dismal prognosis of high-grade brain tumors, and following the encouraging safety profile and tolerance demonstrated in the ongoing phase 1 clinical trial at the Medical College of Wisconsin, we believe it is appropriate to initiate an EAP. This will enable more patients to potentially benefit from the treatment," said Trevor Brown, CEO of IQ-AI.

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