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2 May 2025 13:28
IN BRIEF: IQ-AI applies for breakthrough therapy designation for GaM
IQ-AI Ltd - London-based medical services company - Says subsidiary Imaging Biometrics LLC has applied for breakthrough therapy designation from the US Food & Drug Administration for its oral gallium maltolate therapy. Its phase 1 trial is evaluating the therapy as a potential treatment for adult patients with recurrent or refractory glioblastoma IDH-wildtype, with preliminary findings suggesting an overall survival of 34.1 months from initial diagnosis. This significantly exceeds the median survival of 14 to 15 months reported for patients undergoing standard treatment, though IQ-AI notes that caution is appropriate when considering the results due to the size of the trial population. The FDA is required to respond to IQ-AI's application within 60 days.
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