NEW YORK – Telix Pharmaceuticals on Tuesday said it submitted a new drug application to the US Food and Drug Administration for approval of the LAT1- and LAT2-targeted PET imaging agent Pixclara (TLX101-CDx) as a test to characterize treatment-related changes in patients with progressive or recurrent glioma.
Melbourne, Australia-based Telix is also developing Pixclara as a potential companion diagnostic for its LAT1-targeted radiopharmaceutical agent TLX101. The FDA has granted fast-track and orphan drug designations to Pixclara for the characterization of glioma.
In the Phase I IPAX-2 trial, Telix researchers are evaluating the safety of ascending radioactive doses of iodine-131-labeled TXL101 in combination with standard-of-care therapy in newly diagnosed patients with glioblastoma. And in IPAX-Linz, a Phase II investigator-initiated study at the Kepler University Hospital in Linz, Austria, researchers aim to investigate the clinical utility of TLX101 as a second-line therapy for glioblastoma in 10 patients.
LAT1 and LAT2 are membrane transport proteins that are highly expressed in certain solid tumors, including central nervous system cancers. Because these receptors are expressed on both sides of the blood-brain barrier, Telix views them as favorable targets for delivery of radiation for primary CNS malignancies and metastases derived from non-CNS cancers such as lung and breast.
In a statement, Telix CEO Kevin Richardson said the company anticipates that Pixclara will be commercially available in 2025, pending FDA approval.