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.
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