Telix Pharmaceuticals reports positive results from Phase 2 study of TLX101 in glioma
From GlobeNewswire: 2025-04-15 18:37:00
Telix Pharmaceuticals announced preliminary results from the Phase 2 IPAX-Linz study of TLX101 in recurrent high-grade glioma, showing a median overall survival of 12.4 months from treatment initiation. The study, which included eight patients, demonstrated encouraging efficacy data with no serious adverse events reported. TLX101 continues to show potential for improving outcomes in patients with high-grade glioma, particularly those with MGMT unmethylated tumors. Professor Josef Pichler commented on the positive results, highlighting the need for higher therapeutic doses in future studies. Dr. David Cade expressed optimism for the new treatment options and thanked the research team for their efforts.
Additionally, Telix is continuing to investigate TLX101 in front-line and recurrent settings, with the Phase 1/2 study IPAX-2 still recruiting patients. The company has submitted for ethics approval for a registration-enabling study in recurrent glioblastoma, aiming to start patient enrollment in Australia in the second half of 2025. Following a successful pre-IND meeting with the FDA, Telix plans to submit an IND application in the first half of 2025, with the goal of commencing the study at U.S. sites later in the year. TLX101, an orphan drug, targets L-type amino acid transporter 1 and has shown promise in treating glioma. Telix is focused on developing and commercializing radiopharmaceuticals to address unmet medical needs in oncology and rare diseases. Telix Pharmaceuticals Limited has issued a disclaimer regarding the information and opinions in their announcement, stating that they are subject to change without notification. The company disclaims any obligation to update or revise the information contained in the announcement. Forward-looking statements regarding future events, financial performance, and business developments are included in the announcement, with a caution that actual results may differ. Telix Pharmaceuticals holds trademarks for its products and logos. TLX101, also known as 131I-iodofalan, is a product under development by Telix Pharmaceuticals. Clinical trial data and research studies are referenced in the announcement.
Read more at GlobeNewswire: IPAX-Linz Study Reports Promising Efficacy for TLX101