First Patient Dosed in Phase III Study of TLX591-CDx Illuccix for Prostate Cancer Imaging in Chinese Patients
Melbourne, Australia – Telix Pharmaceuticals Limited (ASX: TLX) announced today that the first patient has been dosed in China in the pivotal Phase III registration study of TLX591-CDx (Illuccix®) for the imaging of prostate cancer using positron emission tomography (PET).
The Phase III study, which is a collaboration with Telix’s strategic partner Grand Pharmaceutical Group Limited, aims to establish the diagnostic utility of TLX591-CDx in Chinese patients with biochemically recurrent (BCR) prostate cancer. The study will enroll up to 110 patients and is intended to bridge the marketing authorization granted to Illuccix by the United States Food and Drug Administration (FDA) to the Chinese population.
Prostate cancer is on the rise in China, with approximately 115,000 men being diagnosed each year, and the number increasing by approximately 6% annually. The availability of advanced PSMA-PET imaging is crucial for the accurate diagnosis and management of prostate cancer. Telix’s collaboration with Grand Pharma aims to bring this advanced imaging technique closer to Chinese men with prostate cancer.
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 and his clinical research team at Zhongnan Hospital of Wuhan University, as well as the patients who will contribute to this important study, said Dr. Shams UL Arifeen, Regional Medical Director, Telix Asia Pacific.
The Phase III Illuccix China study is a significant step towards obtaining marketing authorization for TLX591-CDx in China. The study will compare the diagnostic utility of TLX591-CDx in Chinese and Western prostate cancer populations, ultimately supporting a future marketing authorization application.
About Telix Pharmaceuticals Limited
Telix Pharmaceuticals Limited is a biopharmaceutical company focused on the development and commercialization of diagnostic and therapeutic radiopharmaceuticals. With operations in Australia, the United States, Europe, and Japan, Telix aims to address significant unmet medical needs in oncology and rare diseases. Its lead product, Illuccix® (TLX591-CDx), has been approved by the U.S. FDA, Australian Therapeutic Goods Administration, and Health Canada. Telix is also progressing marketing authorization applications for Illuccix in the United Kingdom and the European Union.
About Grand Pharmaceutical Group Limited
Grand Pharmaceutical Group Limited is an international pharmaceutical company specializing in technological innovation. With a focus on patient needs, Grand Pharma invests in global innovative products and advanced technologies to provide advanced treatment solutions to patients worldwide. Its core businesses include pharmaceutical technology, nuclear medicine anti-tumour diagnosis and treatment, and cerebro-cardiovascular precision interventional diagnosis and treatment technology and biotechnology.
Telix Pharmaceuticals and Grand Pharma’s collaboration in the Phase III study of TLX591-CDx represents a significant advancement in bringing PSMA-PET imaging to Chinese men with prostate cancer. The successful completion of this study will pave the way for improved diagnosis and management of prostate cancer in China.
