Telix has dosed the first Chinese patient in the pivotal Phase III registration trial of TLX591-CDx (Illuccix), a kit designed to prepare 68Ga-PSMA-11 for PET imaging of prostate cancer.
The Phase III open-label, single-arm, prospective multicenter Illuccix China study is conducted in patients with biochemically recurrent (BCR) prostate cancer.
It is intended to serve as a bridge to the marketing authorisation granted by the US Food and Drug Administration to Illuccix.
In collaboration with Telix’s strategic partner for the Greater China region, Grand Pharmaceutical Group, the study aims to demonstrate that the diagnostic utility of TLX591-CDx is compatible with both Chinese and Western populations.
The trial will enrol a maximum of 110 patients who have BCR prostate cancer.
The collected data will be used to support an application for marketing authorisation of TLX591-CDx in China in the future.
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Telix Asia-Pacific regional medical director Dr Shams UL Arifeen said: “We are pleased to have commenced this study, which brings advanced PSMA-PET imaging one step closer for Chinese men with prostate cancer.
“With our strategic collaborator in the region, Grand Pharma, we would like to express our gratitude to Dr Yong He, principal investigator at Zhongnan Hospital of Wuhan University as well as his clinical research team, and the patients who will contribute to this important study.”