Posted: 4 December 2024
Telix and Grand Pharma today announce that a first patient has been dosed in the Phase III ZIRCON-CP trial of TLX250-CDx positron emission tomography (PET) imaging of clear cell renal cell carcinoma (ccRCC). The patient was successfully dosed and imaged at Beijing Cancer Hospital in Beijing, China.
ZIRCON-CP is a multi-centre Phase III registration trial in China intended to bridge to Telix’s global Phase III ZIRCON trial, which met all co-primary and secondary endpoints, including showing 86% sensitivity and 87% specificity, and a mean positive-predictive value (PPV) of 93% for ccRCC[1]. The trial, which will enrol up to 82 patients, is being conducted in collaboration with the Company’s strategic partner for the Greater China region, Grand Pharma, to demonstrate that the diagnostic utility of TLX250-CDx is equivalent in Chinese and Western populations. The clinical data from ZIRCON-CP is intended to support future marketing authorisation applications for this breakthrough technology.
Greater China represents a major market opportunity for radiopharmaceuticals, including TLX250-CDx, driven by increasing cancer incidence rates and an investment in installation of PET/CT cameras. In China alone – 73,000 people are newly diagnosed with kidney cancer each year[2].
Dr David N. Cade, Chief Medical Officer at Telix said, “Dosing and imaging a first patient in the ZIRCON-CP trial is a significant milestone for Telix and our partner Grand Pharma. We would like to thank Professor Peng Du and his team, as well as the patients who will contribute to this important trial, helping to advance TLX250-CDx towards regulatory filings in Greater China, where there is currently critical unmet medical need.”
TLX250-CDx has not received a marketing authorisation in any jurisdiction
