Telix Pharmaceuticals (ASX:TLX) has announced that the first patient has been dosed in its prostate-specific membrane antigen (PSMA) targeting ‘ProstACT’ therapeutic program.
The program is exploring TLX591 in areas of unmet medical need across the full prostate cancer treatment journey.
Telix said its ProstACT study program is evaluating the efficacy of its lutetium-177 (177Lu)-labelled therapeutic antibodies in all stages of prostate cancer.
The first patient, dosed at Princess Alexandra Hospital in Brisbane, was treated as part of the ProstACT SELECT clinical trial. This is a Phase I radiogenomics study running concurrently to the pivotal Phase III study, ProstACT GLOBAL.
Telix said the goal of ProstACT SELECT is to compare 68Ga-PSMA (gallium-based imaging) and 177Lu-PSMA (lutetium-based therapy), specifically exploring the biodistribution and tumour uptake of small molecule and antibody-based targeting in men with PSMA-expressing mCRPC.
“Demonstrating the ‘theranostic’ approach, the study is designed to inform optimal patient selection for 177Lu antibody therapy, with the goal of enabling indication expansion for Telix’s PSMA therapeutic portfolio,” said the company.
ProstACT SELECT is a multi-centre study and will enrol up to 50 patients. It is expected to take approximately 12 months to complete.
Principal investigator and consultant medical oncologist at Princess Alexandra Hospital, Professor Kenneth O’Byrne, said, “PSMA-targeting is widely considered to be the vanguard of prostate cancer treatment and we are therefore excited to have dosed a first patient in this important series of studies of Telix’s lead candidate for prostate cancer therapy. The ProstACT study builds on an already significant body of clinical data for TLX591, which has potential to transform patient outcomes across the full prostate cancer treatment journey.”
Telix chief medical officer Dr Colin Hayward added, “Dosing a first patient in the ProstACT program is a significant milestone for Telix. SELECT is part of the Company’s clinical and commercial strategy to develop TLX591 across multiple points from early-stage, localised disease all the way through to advanced metastatic disease. This study will add value and clinical insight to the platform, whilst also supporting potential indication expansion based on a ‘theranostic’ approach. We wish to express our gratitude to Professor Kenneth O’Byrne and his clinical team, as well as the patients who will contribute to the study.”