Telix Pharmaceuticals (ASX.TLX) has announced that its Japanese subsidiary (Telix Japan) and partner Kanazawa University have received Clinical Trial Notification (CTN) clearance to commence a phase one trial of its prostate cancer imaging product TLX591-CDx.
The clearance was granted by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).
Telix said its collaboration with Kanazawa University commenced in December 2020. It will enrol ten patients with advanced prostate cancer.
The purpose of the trial is to obtain preliminary clinical data in a suitable patient population, confirming that the targeting and pharmacology of TLX591-CDx (Kit for the preparation of 68Ga-PSMA-11 injection) is equivalent to non-Japanese patients.
The company said the clinical data could support future planning discussions with the objective of PMDA product approval in Japan, aligning with the marketing authorisations already submitted in the US, EU, Canada and Australia.
Professor Seigo Kinuya, Professor of Nuclear Medicine at the Kanazawa University Hospital, Department of Nuclear Medicine, Chair of the Japanese Society of Nuclear Medicine, and Chair of the National Conference for Nuclear Medicine Theranostics said, “68Ga-PSMA-11 has been studied widely and intensively across the globe outside of Japan. Clinical data have been accumulated and its diagnostic efficacy and clinical application have been well characterised in guidelines in nuclear medicine and urology, worldwide. This first clinical trial of 68Ga-PSMA-11 prostate imaging in Japan is a crucial milestone to pave the way to provide new diagnostics to Japanese prostate cancer patients.”
Telix Pharmaceuticals Japan president Dr Shintaro Nishimura added, “This study is the first formal clinical trial in Japan of a gallium labelled PET imaging agent, which many Japanese nuclear medicine and urology physicians have been waiting for. We would like to express our appreciation to our pioneering colleagues at Kanazawa University's Departments of Nuclear Medicine and Urology, the Innovative Clinical Research Center of Kanazawa University Hospital, the Kanazawa Advanced Medical Center, ATOX Co. Ltd and IRE ELiT (Belgium) for their exceptional support and collaboration in this project.”