Melbourne (Australia) and Kyoto (Japan) – 25 May 2021. Telix announces the first patient has been dosed in a clinical study in Japan using Telix’s investigational prostate cancer imaging product, Illuccix®.
Telix is pleased to announce that the first patient has been dosed in a clinical study in Japan using Telix’s investigational prostate cancer imaging product TLX591-CDx (Illuccix®, Kit for the preparation of 68Ga-PSMA-11 injection). The study is an academic collaboration between Telix and Kanazawa University.
The study will enrol ten patients with advanced prostate cancer and is the first clinical evaluation of gallium-based PSMA imaging in Japan. The objective is to obtain safety data in a representative Japanese patient population, and to demonstrate that the targeting and biodistribution of TLX591-CDx in Japanese patients is consistent with international experience. Clinical data may facilitate development planning discussions with the PMDA and other Asian regulators.
Telix Japan President Dr. Shintaro Nishimura added, “This is the first study in Japan where a gallium based PSMA imaging agent is being systematically evaluated. Dosing the first patient represents a significant first step for the Japanese domestic medicine community to deliver innovative benefits to Japanese prostate cancer patients. We would like to express our appreciation to Dr. Inaki, the study’s principal investigator at Kanazawa University Hospital, the investigators and the study team for their excellent collaboration and, most importantly, the patients who will participate in this study.”
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About Telix Pharmaceuticals (ASX: TLX)
Telix is a late-stage radiopharmaceutical company developing a broad portfolio of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix’s products address significant unmet medical needs in prostate, kidney, glioblastoma (brain) and hematologic (blood) cancers, as well as a range of immunologic and high value rare diseases.
The Company is headquartered in Melbourne, Australia with international operations in Belgium, Japan, and the United States, and is listed on the Australian Securities Exchange (ASX: TLX).
Telix’s lead product, Illuccix® (TLX591-CDx) for prostate cancer imaging, has been accepted for filing by the U.S. Food and Drug Administration (FDA) and has been granted Priority Review status by the Australian Therapeutic Goods Administration (TGA). Telix is also progressing marketing authorisation applications for Illuccix® in the European Union and Canada. None of Telix’s products have currently received a marketing authorisation in any jurisdiction. For more information visit www.telixpharma.com and follow Telix on Twitter (@TelixPharma) and LinkedIn.