• IPAX-2 study of TLX101-Tx (¹³¹I-iodofalan) has completed patient enrolment.
• Maximum dose reached with no dose-limiting toxicities observed.
• TLX101-Tx is also the subject of a pivotal trial, IPAX BrIGHT, which is actively dosing patients with recurrent glioblastoma.
  
  

-- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”)  announces that the IPAX-2 study¹ of TLX101-Tx (¹³¹I-iodofalan) in patients with newly diagnosed glioblastoma has completed patient enrolment. No dose-limiting toxicities (DLTs) have been observed to date, including with two doses of 5GBq (total administered activity of 10GBq), the maximum administered dose in the study.

IPAX-2 is an international, multicenter, open-label Phase 1 dose finding study to evaluate the safety and tolerability of TLX101-Tx in combination with post-surgical standard-of-care treatment (external beam radiation therapy and temozolomide) in primary glioblastoma. Twelve patients were enrolled into three dose escalating cohorts across four sites in Australia, Austria and the Netherlands to assess the safety and tolerability, and to assess the maximum tolerated dose (MTD) for further development. Patients remain on standard-of-care treatment until study completion, after which the MTD primary endpoint will be confirmed.

Dr. David N. Cade, Group Chief Medical Officer, Telix, commented, "We are pleased to have completed enrolment in IPAX-2, an important milestone in the development of TLX101-Tx as a potential treatment for first-line glioblastoma. The tolerability amongst patients, and the absence of dose-limiting toxicities observed on this study strongly support the continued development of this targeted radiopharmaceutical candidate. We thank the principal investigators, their clinical teams, and the patients who have participated in this important research."

TLX101-Tx is currently also under evaluation in the pivotal IPAX BrIGHT² trial to assess the safety and efficacy of TLX101-Tx in combination with chemotherapy (lomustine), compared to chemotherapy alone in patients with recurrent glioblastoma (last line). IPAX BrIGHT is actively enrolling and dosing patients in Australia and the Netherlands and is also approved in Austria and Belgium with enrollment to begin soon. This marks the first radiopharmaceutical therapy to enter Phase 3 development for glioblastoma.

Telix's PET imaging candidate TLX101-Px (floretyrosine F 18) has been used across the IPAX series of trials to identify participants with overexpressed LAT1 as suitable candidates for TLX101-Tx therapy, and to provide baseline and follow-up information on tumor response and progression.