Telix Pharmaceuticals has dosed the first patient in its IPAX BrIGHT phase III trial of TLX101-Tx (iodine-131 iodofalan), a radiopharmaceutical therapy for recurrent glioblastoma.
The patient was dosed at Austin Health in Melbourne, Australia. IPAX BrIGHT is a global, multicenter, open-label study assessing TLX101-Tx in combination with the chemotherapy agent lomustine versus chemotherapy alone in patients with radiographically confirmed recurrent glioblastoma at first recurrence. Telix's investigational PET imaging agent TLX101-Px (Pixclara) will be used for patient selection and tumor response assessment in the trial.
TLX101-Tx targets L-type amino acid transporter 1 (LAT1), a transporter that enables the agent to cross the blood-brain barrier and deliver therapy directly to the tumor. Earlier trials reported a median overall survival of 13 months from treatment initiation in the IPAX-1 study and 12.4 months in the investigator-initiated IPAX-Linz trial. The drug has received orphan drug designation in the U.S. and Europe for glioma treatment.
The study has received regulatory approval in Australia, Austria, Belgium, and the Netherlands, with additional approvals being sought.
