Telix Pharmaceuticals Limited (NASDAQ: TLX) completed patient enrollment for its IPAX-2 study evaluating TLX101-Tx in patients with newly diagnosed glioblastoma, the company announced May 19.

The Phase 1 dose-finding study enrolled 12 patients across three dose escalating cohorts at four sites in Australia, Austria and the Netherlands. The study reached its maximum administered dose of 10GBq total activity with no dose-limiting toxicities observed.

IPAX-2 evaluates TLX101-Tx in combination with standard post-surgical treatment including external beam radiation therapy and temozolomide. The international, multicenter, open-label study aims to assess safety, tolerability and determine the maximum tolerated dose for further development.

TLX101-Tx is currently under evaluation in the pivotal IPAX BrIGHT trial for recurrent glioblastoma patients. The Phase 3 study compares TLX101-Tx combined with lomustine chemotherapy against chemotherapy alone. The trial is actively enrolling patients in Australia and the Netherlands, with enrollment set to begin in Austria and Belgium.

TLX101-Tx targets L-type amino acid transporter 1, which is overexpressed in glioblastoma. The radiopharmaceutical therapy uses a small molecule approach to cross the blood-brain barrier. Previous IPAX-1 study results showed median overall survival of 13 months from treatment initiation and 23 months from initial diagnosis.

The drug has received orphan drug designation in the United States and Europe for glioma treatment. Glioblastoma affects approximately 22,000 new patients annually in the United States and has a typical survival duration of 12-15 months from diagnosis despite current treatments.

TLX101-Tx has not received marketing authorization in any jurisdiction and remains investigational.