First Patient Dosed in Japanese Prostate Cancer Imaging Study

MELBOURNE, Australia and KYOTO, Japan, May 25, 2021 (GLOBE NEWSWIRE) — Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces 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 enroll 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.

Anri Inaki MD PhD, Principal Investigator of the study, said, “The development of PSMA prostate imaging in Japan has been eagerly awaited by prostate cancer patients and the urology and nuclear medicine community. We are delighted to announce this cornerstone event as a collaborative achievement between Professor Mizokami of Urology, Professor Murayama of the Innovative Clinical Research Center (iCREK), and Professor Kinuya of Nuclear Medicine at Kanazawa University Hospital, along with Kanazawa Advanced Medical Center (KadMedic), ATOX Co. Ltd, IRE ELiT (Belgium) and Telix.”

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.”

About Telix Pharmaceuticals Limited

Telix is a clinical-stage biopharmaceutical company focused on the development of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan, and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit www.telixpharma.com and follow Telix on Twitter (@TelixPharma) and LinkedIn.

Telix’s lead investigational product, Illuccix^® (TLX591-CDx) for prostate cancer imaging, has been accepted for filing by the U.S. FDA,¹ and is under priority evaluation by the Australian Therapeutic Goods Administration (TGA).² Telix is also progressing marketing authorisation applications for Illuccix^® in the European Union³ and Canada.⁴ None of Telix’s products have received a marketing authorisation in any jurisdiction.

¹ ASX disclosure 24/11/20.
² ASX disclosure 14/04/21.
³ ASX disclosure 1/05/20.
⁴ ASX disclosure 16/12/20.