Australian biotechnology company, Telix Pharmaceuticals, has announced that it has dosed the first patient as part of its Phase III ZIRCON-CP trial of TLX250-CDx, a form of positron emission tomography (PET) imaging designed to examine clear cell renal cell carcinomas.
Telix is working on the study with Hong Kong-based Grand Pharmaceutical Group which has dosed the first patient in China as part of a multi-centre Phase III registration trial which is intended to back up the company’s previous global Phase III ZIRCON trial, which met all co-primary and secondary endpoints, including an 86% sensitivity and 87% specificity for the method.
TLX250-CDx is an investigational PET agent designed to characterise indeterminate renal masses (IRMs) whilst remaining non-invasive. The company’s previous Zirconium in Renal Cancer Oncology trial, called ZIRCON (NCT03849118), evaluated 284 patients meeting all primary and secondary endpoints.
David 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."
The upcoming ZIRCON-CP trial will enrol up to 82 patients and is being conducted in collaboration with the company's strategic partner in China Grand Pharma, to demonstrate that TLX250-CDx is as capable in Chinese populations as in Western populations. The company says results from the two trials will be used to reinforce future marketing authorisation applications.
Away from its clinical trials, Telix already runs an expanded access program (EAP) in the US as well as named patient programs (NPPs) in Europe, and a special access scheme (SAS) in Australia to allow continued access to TLX250-CDx to patients for whom there are no comparable or satisfactory alternate options.
Elsewhere in the world of PET diagnostics, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Tauvid (flortaucipir), a diagnostic imaging agent developed by Eli Lilly.
