Japanese Prostate Cancer Imaging Trial Meets Study Objectives

Melbourne (Australia) and Kyoto (Japan) – 8 February 2022. Telix and Kanazawa University announce that the Phase I clinical study of TLX591-CDx for prostate cancer imaging in Japanese patients has met its objectives

In collaboration with Kanazawa University, Telix is pleased to announce that the Phase I clinical study of the Company’s investigational prostate cancer imaging product in Japanese patients has reported the study results. The study has met its objectives, demonstrating safety and tolerability when using TLX591-CDx (Kit for the preparation of gallium-68 (68Ga) PSMA-11 injection).

This study is evaluating the safety, tolerability, radiation dosimetry and pharmacokinetics of TLX591-CDx in Japanese patients. No serious adverse events (SAEs) were observed in any participants, and whole-body and organ-specific radiation dosimetry demonstrated no difference between Japanese and non-Japanese populations. The pharmacokinetics of TLX591-CDx in Japanese patients was also comparable to that of previous studies reported in Western populations.

The study, conducted at Kanazawa University Hospital in Japan and supported by Telix, reported topline results in collaboration with Kanazawa University Hospital. In total, ten patients with prostate cancer were enrolled from May to August 2021. All patients underwent dosing with TLX591-CDx followed by positron emission tomography (PET) imaging. All enrolled patients had completed the study by September 2021.

Professor and Chairman, Department of Clinical Development, Kanazawa University Hospital, Dr. Toshinori Murayama, stated, “We are proud of our quick completion of this important Phase I study. We are highly encouraged by both the early safety and tolerability data, as well as the comparability of the pharmacokinetics and dosimetry of 68Ga-PSMA-11 between Japanese and non-Japanese populations.”

Dr. Shintaro Nishimura, President of Telix Pharmaceuticals Japan, added, “I would like to express my sincere gratitude to the doctors at Kanazawa University and the prostate cancer patients who enabled us to complete this clinical trial in record time. I believe that this is the result of the desire of doctors and patients to see this investigational drug available to patients in Japan. These results will serve as a useful basis for advancing the TLX591-CDx program towards regulatory submissions across Asia including in Japan. We are committed to working to bring this candidate, which was recently approved in the United States and Australia, to market in Japan as soon as possible.”

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