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Application: FDA Breakthrough Therapy Designation
Application: FDA Breakthrough Therapy Designation.
About this update from Imaging Biometrics Limited
[{"type":"text","content":"\n\nIQ-AI Ltd\n(\"IQ-AI\" or the \"Company\")\n \nImaging Biometrics Applies for FDA Breakthrough Therapy Designation\nMay 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. \n \nThe 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).\n \nBreakthrough 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.\n \n\"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.\n--ENDS-\n \nThe Directors of the Company accept responsibility for the contents of this announcement.\n \nFor further information, please contact:\n \n\n\n\n\nIQ-AI Ltd\nTrevor Brown/Dr Al Musella/Brett Skelly/Michael Schmainda\nTel: 020 7469 0930\n\n\n\n\nPeterhouse Capital Limited (Financial Adviser and Broker)\nLucy Williams/Heena Karani\nTel: 020 7220 9797\n\n\n\n\n \nAbout Imaging Biometrics® LLC: IB is a wholly-owned subsidiary of IQ-AI Limited, (LON: IQAI) (OTCQB: IQAIF), and focuses on delivering quantitative imaging platforms and therapeutics that transform how clinicians diagnose and treat patients more efficiently and effectively. For more information about Imaging Biometrics, visit the company's website at www.imagingbiometrics.com. Follow IB on X, IQAI_IB.\n \n ...