Application: FDA Breakthrough Therapy Designation
Imaging Biometrics applies for FDA Breakthrough Therapy Designation for oral gallium maltolate for glioblastoma.
- Overall survival from initial diagnosis (Phase 1 GaM trial) 34.1 months
- Median overall survival standard of care (GBM IDH-wildtype) 14-15 months
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May 2, 2025 - Imaging Biometrics, LLC (IB), a wholly owned subsidiary of IQ-AI Ltd (LSE: IQAI), has today applied to the U.S. Food and Drug Administration for 'Breakthrough Therapy Designation' for its innovative oral gallium maltolate ("GaM") therapy.
The Phase 1 trial is evaluating oral GaM as a potential treatment for adult patients with recurrent or refractory glioblastoma ("GBM") IDH-wildtype. Preliminary findings suggest an overall survival ("OS") of 34.1 months from initial diagnosis - whilst caution due to the size of the trial population is appropriate, this significantly exceeds the median OS of 14-15 months (from initial diagnosis) reported for patients undergoing standard of care treatment (surgical resection, radiation, and chemotherapy).
Breakthrough Therapy Designation is granted to therapies that demonstrate substantial improvement over existing treatments based on early clinical evidence. While similar to the Fast Track Designation already received, Breakthrough Therapy Designation provides more intensive FDA guidance and senior-level organizational support. The FDA is required to respond to this request within 60 days.
"Our decision to apply for Breakthrough Therapy Designation reflects our optimism in the potential of oral GaM as a treatment for recurrent or refractory glioblastoma ("GBM") IDH-wildtype " said Trevor Brown, CEO of IQAI.
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