IQ-AI Limited has announced promising preliminary results from a Phase 1 clinical trial conducted by its subsidiary, Imaging Biometrics LLC, involving a novel treatment for recurrent/refractory glioblastoma. The oral agent, Gallium Maltolate (GaM), administered daily, has shown signs of efficacy in patients, with no serious adverse events reported.
The trial, which is close to completing its enrollment phase, has 23 subjects with evaluable data. These patients have demonstrated an overall survival (OS) of 32 months from initial diagnosis, compared to the typical OS of 8-9 months for all glioblastoma patients, and up to 20 months for those undergoing redo surgeries. Notably, 19 of the evaluable subjects in this study underwent redo surgeries.
The data suggests that overall survival is 14 months from the start of GaM treatment. This is a positive indication of the treatment's potential anti-tumor activity, according to Trevor Brown, CEO of IQAI. However, he emphasized that the data is preliminary and that further research is necessary.
While progression-free survival (PFS) for the trial participants was reported at 2 months, which aligns with the current standard therapy PFS of 1-2 months for recurrent glioblastoma, the patients may have experienced benefits from disease stability, as indicated by their extended OS.
The trial also explores more accurate ways to assess PFS through advanced quantitative imaging, like the FTB maps provided by Imaging Biometrics, which may offer further insights into the treatment's effectiveness.
The promising early results of this Phase 1 study are based on a press release statement from IQ-AI Limited. As the trial progresses, more comprehensive data will be required to validate the efficacy and safety of oral GaM for glioblastoma patients.
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