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First Patient Dosed in Clinical Study of TLX250-CDx in Bladder Cancer

Melbourne (Australia) – 23 June 2021. Telix announces that a first patient has been dosed in a Phase I study of TLX250-CDx in patients with bladder cancer.

Telix is pleased to announce that a first patient has been dosed in a Phase I study of TLX250-CDx (89Zr-DFO-girentuximab) in patients with urothelial carcinoma or bladder cancer at Fiona Stanley Hospital in Perth, Western Australia.

The objective of the ZiP-UP (Zirconium-girentuximab PET in Urothelial Cancer Patients) study is to evaluate the feasibility of using TLX250-CDx positron emission tomography/computed tomography (PET/CT) in the detection of localised and metastatic urothelial carcinoma or bladder cancer. Carbonic anhydrase IX (CA9) is a target that is over-expressed in many solid tumours, including urologic malignancies. ZiP-UP is an investigator-led study conducted by Professor Dickon Hayne at the Fiona Stanley Hospital, with the goal of evaluating how CA9 imaging can be utilised for cancer diagnosis and staging, and to develop a deeper understanding of the utility of CA9 as a therapeutic target in this patient population.

ZiP-UP is the first in a series of studies that will harness TLX250-CDx to evaluate CA9 expression in cancers other than renal cancer, currently the focus of the ZIRCON (imaging) and STARLITE (therapy) studies. Other collaborative studies are in development for ovarian, triple negative breast, colorectal, head and neck, lung, and pancreatic cancers.

Telix CEO, Dr Christian Behrenbruch added, “We are pleased that a first patient has been dosed in this study exploring the clinical utility of TLX250-CDx to image other cancers, beyond renal cancer, and in indications where conventional imaging has limitations. This candidate has been granted Breakthrough Therapy designation by the US FDA for renal cancer imaging and therefore it is meaningful to test the potential of CA9 targeting in other cancers with the goal of rapid indication expansion beyond the initial kidney cancer application. We wish to express our gratitude to Professor Dickon Hayne and his clinical team, as well as the patients that will contribute to the study.”

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