
Telix Pharmaceuticals completes enrolment for glioblastoma trial
Australian radiopharmaceutical company Telix Pharmaceuticals (ASX:TLX) completed patient enrolment for its international, multicentre Phase 1 IPAX-2 clinical trial.
The study is evaluating TLX101-Tx (131I-iodofalan) in patients with newly diagnosed glioblastoma, an aggressive form of brain cancer.
No dose-limiting toxicities have been observed to date, even at the study's maximum administered dose of 10GBq, delivered across two 5GBq treatments.
The open-label trial enrolled 12 patients across three dose-escalating cohorts located in Australia, Austria, and the Netherlands.
The study aims to evaluate the safety, tolerability, and maximum tolerated dose of the therapy when combined with standard post-surgical treatments, including radiation and chemotherapy.
Dr David N. Cade, Telix’s Group Chief Medical Officer, expressed optimism regarding the milestone, noting that the excellent tolerability profile strongly supports the ongoing development of this targeted candidate.
Patients will continue their standard-of-care regimen until the study's conclusion, at which point the primary endpoint will be confirmed.
Telix is advancing its pivotal Phase 3 IPAX BrIGHT trial, which marks a historic milestone as the first radiopharmaceutical therapy to enter Phase 3 development for glioblastoma.
The larger study evaluates TLX101-Tx in patients with recurrent disease.
Throughout these trials, Telix is utilising its companion PET imaging agent, TLX101-Px, to identify eligible patients with overexpressed LAT1 proteins and monitor tumour response.