IQ-AI Ltd (LSE:IQAI, OTCQB:IQAIF) told investors that its wholly owned subsidiary, Imaging Biometrics, has submitted an application to the US Food and Drug Administration (FDA) for Breakthrough Therapy designation.
The application is for its oral gallium maltolate therapy, for treating adult patients with a certain kind of brain tumour (recurrent or refractory glioblastoma IDH-wildtype).
Preliminary Phase 1 trial data indicates an overall survival of 34.1 months from initial diagnosis, exceeding the typical survival of 14 to 15 months seen with standard treatment.
Breakthrough Therapy Designation offers more intensive guidance and higher-level FDA support than Fast Track status. The agency is expected to respond within 60 days.
"Our decision to apply for Breakthrough Therapy Designation reflects our optimism in the potential of oral GaM,” IQ-AI chief executive Trevor Brown said in a statement.