Melbourne (Australia) – 19 August 2021. Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’, the ‘Company’) today releases details of two ancillary studies under the ProstACT program that significantly extend the evaluation of Telix’s TLX591 antibody-directed 177Lu (lutetium) therapeutic platform into areas of unmet medical need across the full prostate cancer treatment journey.
The two additional studies will run alongside the Phase III ProstACT GLOBAL study.1 This expanded ProstACT study program scope will enable Telix to evaluate the efficacy and safety of PSMA- targeted lutetium therapy in early-stage, localised disease all the way through to advanced metastatic disease (known as metastatic castrate-resistant prostate cancer, or mCRPC).
The two additional studies are:
- ProstACT SELECT, a Phase I radiogenomics study with the goal of comparing 68Ga-PSMA (gallium) and 177Lu-PSMA (lutetium), specifically exploring the biodistribution differences between small molecule and antibody-based targeting. The study is designed to inform optimal patient selection for Telix’s antibody-based 177Lu therapy, with the goal of enabling indication expansion for Telix’s PSMA therapeutic portfolio. ProstACT SELECT is a multi- centre study and will enroll up to 50
- ProstACT TARGET, a Phase II study to evaluate TLX591 in combination with external beam radiation therapy (EBRT) in patients with oligometastatic prostate-specific membrane antigen (PSMA) expressing disease, providing data in early prostate cancer relapse. The study, which targets enrollment of 50 patients across multiple Australian sites, is a collaboration with Telix’s strategic partner, GenesisCare, and will be conducted within its GenesisCare will co-fund the study alongside Telix.
This expanded study program will inform the Company’s long-term clinical and commercialisation strategies for the TLX591 therapeutic candidate and generate multiple opportunities for near-term data readouts throughout the program duration.
Human Research Ethics Committee (HREC) has granted approval to commence the SELECT study. Clinical Trial Notification (CTN) clearance by the Australian Therapeutic Goods Administration (TGA) has also been received.
Telix CEO Dr Christian Behrenbruch commented, “Telix’s ultimate objective is to evaluate the use of our PSMA-targeting radionuclide therapies in prostate cancer from first diagnosis to advanced metastatic disease. The biology of prostate cancer and clinical utility of radionuclide therapy will have distinct application in each of these settings. We believe there is a clear rationale for integrating molecularly-targeted radiation (MTR) with standard of care at each stage in the patient journey and these earlier studies have potential to rapidly expand the scope of future clinical indications.”
GenesisCare Founder and CEO Dan Collins added, “We continue to be excited about our collaborative work with Telix to unlock the potential of PSMA as a therapeutic target for the treatment of prostate cancer. Through GenesisCare’s extensive network of cancer care centers, our partnership with Telix on the Phase II ProstACT TARGET trial will enable us to accelerate our scientific understanding of early biochemical recurrence (BCR) and oligometastatic prostate cancer with the potential to improve life outcomes for patients as we shorten the timeline between the development and use of the newest treatment options.”
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan, and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit www.telixpharma.com and follow Telix on Twitter (@TelixPharma) and LinkedIn.
Telix’s lead investigational product, illuccix® (TLX591-CDx) for prostate cancer imaging, has been accepted for filing by the U.S. FDA,2 and is under priority evaluation by the Australian Therapeutic Goods Administration (TGA).3 Telix is also progressing marketing authorisation applications for illuccix® in the European Union4 and Canada.5 None of Telix’s products have received a marketing authorisation in any jurisdiction.