Australian biotechnology company Telix Pharmaceuticals Limited (ASX: TLX) (NASDAQ: TLX) on Tuesday announced preliminary results from the Phase 2 IPAX-Linz study of TLX101 (131I-iodofalan) in recurrent high-grade glioma (brain cancer), substantiating the patient benefit seen in the IPAX-1 study.
A single-arm, Phase 2 investigator-initiated trial (IIT), IPAX-Linz is evaluating the safety, tolerability and preliminary efficacy of TLX101 therapy in combination with external beam radiation therapy (EBRT). The target patient population is patients at first or second recurrence with high-grade gliomas (HGG), including glioblastoma.
In the trial, treatment with TLX101 was well tolerated with no serious adverse events reported. IPAX-Linz demonstrated encouraging preliminary efficacy data, indicating a median overall survival (OS) of 12.4 months from the initiation of treatment with TLX101, or 32.2 months from initial diagnosis. This is consistent with the positive efficacy signal generated in the IPAX-1 study in patients at first recurrence, with only one prior resection and treatment with standard chemoradiotherapy.
Eight patients were included in the study with adaptive dosing of intravenous TLX101 up to administered activity of 4 GBq before, and up to 2 GBq after, second line EBRT, administered in sequential injections.
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