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In the Phase 2 IPAX-LINZ study conducted in Austria, eight patients with recurrent high-grade glioma (first or second recurrence) received intravenous TLX101 before and after second-line external beam radiation therapy (EBRT). TLX101 targets the LAT1 amino acid transporter, which is commonly overexpressed in GBM. The treatment was well tolerated, with no serious adverse events, even at higher doses than previously tested. The median overall survival was 12.4 months from treatment start, which is an improvement over the typical 9.9 months for recurrent GBM treated with EBRT alone.
Telix has an ongoing Phase 2 trial for TLX101 in newly diagnosed GBM (NCT05450744) in Australia, New Zealand, Austria and the Netherlands, and plans are underway for a pivotal trial in recurrent GBM which will hopefully open enrollment in Australia in late 2025 (followed by US site activation and enrollment pending FDA IND approval).