Japanese Prostate Cancer Imaging Trial Meets Study Objectives

MELBOURNE, Australia and KYOTO, Japan, Feb. 08, 2022 (GLOBE NEWSWIRE) — Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) in collaboration with Kanazawa University today announces that the Phase I clinical study of its 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.¹ 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.”

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan, Switzerland and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical need 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 product, gallium-68 (⁶⁸Ga) gozetotide (also known as ⁶⁸Ga PSMA-11) injection for prostate cancer imaging, has been approved by the U.S. Food and Drug Administration (FDA),² and by the Australian Therapeutic Goods Administration (TGA).³ Telix is also progressing marketing authorisation applications for this investigational candidate in Europe⁴ and Canada.⁵

Telix Media Contact

Dr. Stewart Holmstrom
Telix Pharmaceuticals Limited
Director Corporate Communications
Email: stewart.holmstrom@telixpharma.com

Important Information

This announcement does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States, or in any other jurisdiction in which such an offer would be illegal. The securities referred to herein have not been and will not be registered under the United States Securities Act of 1933 (the “U.S. Securities Act”), or under the securities laws of any state or other jurisdiction of the United States and may not be offered or sold within the United States, unless the securities have been registered under the U.S. Securities Act or an exemption from the registration requirements of the U.S. Securities Act is available. This announcement has been authorised for release by Dr. Christian Behrenbruch, Managing Director and Chief Executive Officer. The Telix Pharmaceuticals name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates (all rights reserved).

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¹ Japanese Registry of Clinical Trials identifier: JRCT2041200110
² ASX disclosure 20 December 2021.
³ ASX disclosure 2 November 2021.
⁴ ASX disclosure 10 December 2021.
⁵ ASX disclosure 16 December 2020.