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LONDON - Imaging Biometrics, LLC, a subsidiary of IQ-AI Ltd (LSE:IQAI), has submitted an application for Breakthrough Therapy Designation to the U.S. Food and Drug Administration (FDA) for its oral gallium maltolate (GaM) treatment for glioblastoma. The Phase 1 trial results indicate a potential to extend overall survival in patients with this aggressive brain cancer.
The therapy is being tested on adult patients with recurrent or refractory glioblastoma IDH-wildtype, a particularly aggressive and difficult-to-treat brain tumor. Early trial results have shown an overall survival rate of 34.1 months from initial diagnosis, compared to the median survival of 14-15 months for patients receiving the current standard of care, which includes surgery, radiation, and chemotherapy.
Breakthrough Therapy Designation by the FDA is reserved for drugs that may offer substantial improvements over existing therapies based on preliminary clinical evidence. This designation could expedite the development and review process for GaM, offering additional FDA guidance and support. The application follows the Fast Track Designation that the treatment has already received.
Trevor Brown, CEO of IQAI, expressed optimism regarding the potential of GaM for treating glioblastoma, citing the application for Breakthrough Therapy Designation as a reflection of the company’s confidence in the treatment’s benefits.
The FDA’s decision on the application is expected within 60 days, as per regulatory requirements. This news is based on a press release statement from IQ-AI Ltd.
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