Telix Pharmaceuticals Limited announced that a first patient has been dosed in a Phase II investigator-initiated study of TLX101 in combination with external beam radiation therapy (EBRT) in patients with recurrent high-grade gliomas (HGG), including glioblastoma multiforme (GBM). TLX101 (4-L-[131I] iodo-phenylalanine, or 131I-IPA) is one of Telix's lead therapeutic clinical programs and has been granted orphan drug designation in the U.S. and Europe. TLX101 targets L-type amino acid transporter 1 (LAT-1), typically over-expressed in many malignant tumours, including HGG/GBM.

The IPAX-Linz study, which is being led by Professor Josef Pichler at Kepler University Hospital in Linz, Austria, builds on data generated in the IPAX-1 study. The final results of the IPAX-1 study, reported in September 2022, demonstrated a favourable safety profile and encouraging preliminary therapeutic effect.[1] IPAX-Linz will continue to study the benefit of TLX101 to patients in the second line (refractory) setting at this leading neuro-oncology site in Europe. Targeting recruitment of 10 patients, the goal of this study is to gather additional data on clinical utility.

IPAX-Linz will run concurrently with IPAX-2, which is evaluating TLX101 in combination with post-surgical standard of care comprised of EBRT and temozolomide in newly diagnosed (first line) GBM patients.