First Patient Dosed in Renal Cancer Imaging Study in Japan

Melbourne (Australia) – 18th August 2020. Telix announces the first patient has been dosed in a Phase I/II study of Telix’s renal cancer diagnostic imaging product TLX250-CDx in Japan

Telix Pharmaceuticals Limited is delighted to announce the first patient has been dosed in a Phase I/II study of Telix’s renal cancer diagnostic imaging product TLX250-CDx (89Zr-girentuximab) in Japan.

The objective of the study, termed the “ZIRDAC-JP” (Zirconium Dosing and Comparison in Japan) study is to confirm the safety and tolerability, as well as sensitivity and specificity of positron emission tomography (PET) imaging with TLX250-CDx to detect clear cell renal cell cancer (ccRCC) in Japanese patients.

The ZIRDAC-JP study represents an enormous achievement, being the first commercially sponsored clinical trial in Japan in which a zirconium-based radiopharmaceutical agent has been studied.

The ZIRDAC-JP study has been carefully designed in consultation with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) to collect the necessary data to potentially bridge to Telix’s international, multi-centre Phase III ZIRCON study by confirming that dosing and pharmacology in Japanese patients is consistent with the rest-of-world experience.

We at Telix wish to express our appreciation to Dr Nakaigawa, the ZIRDAC-JP study’s principal investigator at Yokohama City University Hospital, the investigators and the study team for their excellent collaboration, and most importantly the patients who will participate in this trial.

To read full media release please click here.