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Telix Pharmaceuticals Limited (NASDAQ:TLX) on Tuesday released preliminary results from the Phase 2 IPAX-Linz study of TLX101 (131I-iodofalan1) in recurrent high-grade glioma (brain cancer), substantiating the patient benefit seen in the IPAX-1 study.
IPAX-Linz is a single-arm Phase 2 investigator-initiated trial evaluating the safety, tolerability, and preliminary efficacy of TLX101 therapy in combination with external beam radiation therapy (EBRT).
TLX101 (131I-iodofalan or 131I-IPA) is a systemically administered targeted radiation therapy that targets L-type amino acid transporter 1, which is typically over-expressed in glioblastoma.
The target patient population is patients at first or second recurrence with high-grade gliomas (HGG), including glioblastoma.
Treatment with TLX101 was well tolerated, with no serious adverse events reported.
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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 the 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.
IPAX-1 reported a median OS of 13 months from the initiation of treatment with TLX101 or 23 months from the initial diagnosis.
In comparison, recurrent glioblastoma patients treated with EBRT alone have a reported median survival of 9.9 months from treatment.
Eight patients were included in the study with adaptive dosing of intravenous TLX101 up to the administered activity of 4 GBq before and up to 2 GBq after second-line EBRT, administered in sequential injections.
Preliminary results from IPAX-Linz will be presented at the Nuclear Medicine and Neurooncology (NMN) Symposium, which will take place in May.
Telix continues to investigate TLX101 in front-line and recurrent settings. IPAX-2, a Phase 1/2 study in front-line glioblastoma in combination with standard of care and using TLX101-CDx as a companion diagnostic, continues to recruit patients.
Telix has submitted for ethics approval a registration-enabling study of TLX101 in recurrent glioblastoma.
Subject to approval, this will enable patient enrollment to commence at Australian sites in H2 2025, ahead of international expansion.
Following the successful pre-IND meeting with the U.S. Food and Drug Administration (FDA) in Q4 2024, the company is also on track to submit an IND application in H1 2025 to commence the study at U.S. sites in H2 2025.