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NOBLE Study Brings Advanced Prostate Imaging to Rural Australia – First Patient Dosed

MELBOURNE, Australia, Nov. 15, 2021 (GLOBE NEWSWIRE) — Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the first Australian patient has been dosed in the international NOBLE Registry, a global study that aims to improve access for men to state-of-the-art prostate cancer imaging tools. The NOBLE Registry is co-supported by Telix and Brussels-based Oncidium Foundation.

The NOBLE (Nobody Left Behind) Registry is collecting clinical data to inform the development of TLX599-CDx (99mTc-iPSMA), an investigational prostate cancer imaging agent that targets PSMA (prostate specific membrane antigen) using single photon emission computed tomography (SPECT). The Australian arm of the NOBLE study is being led by PhD researcher Peter Tually at TeleMed in collaboration with Clinical Professor Nat Lenzo, and Professor Geoff Currie at Charles Sturt University (CSU), and will recruit prostate cancer patients in the Kalgoorlie, Albany and Geraldton regions in rural Western Australia.

While PSMA-PET1 imaging is emerging as the new standard of care for prostate cancer diagnosis and staging, having been recently included in the updated National Comprehensive Cancer Network Guidelines®,2 access is typically limited outside of major cities and in emerging health care systems. Telix is developing TLX599-CDx as an accessible alternative, particularly for certain countries as well as remote and rural locations where SPECT is the predominant imaging modality.3 TLX599-CDx is part of Telix’s industry-leading portfolio of prostate cancer imaging technologies, which includes Illuccix® (TLX591-CDx, Kit for the preparation of 68Ga-PSMA-11 injection) that recently received approval by the Australian Therapeutic Goods Administration (TGA).4

Nuclear medicine practitioner, Peter Tually, Principal Investigator for the NOBLE Registry study in Australia and Director of TeleMed, a provider of tele-nuclear medicine and paramedic services to rural and remote communities of Western Australia, said, “Our mission is to bring a metropolitan standard of care to the bush and level the playing field where we can. Our involvement in NOBLE takes us a step closer to achieving this, by giving patients local access to the latest prostate cancer imaging tools which could have a profound impact on clinical decisions regarding their treatment.”

The project, according to Professor Currie, “is consistent with CSU leadership in rural health and commitment to addressing social asymmetry, inequity and injustice of health-related outcomes.”

Dr. Christian Behrenbruch, Telix CEO added, “The NOBLE study is an important piece of clinical research which could expedite access to PSMA imaging for patients who might otherwise have to travel long distances or endure significant wait times to access this technology. With the support of investigators such as Peter Tually and Professor Geoff Currie, and their global counterparts, we are recruiting patients at a steady pace, which will pave the way for greater access to PSMA imaging for patients in developing nations, rural and remote areas – first on study use basis, but ultimately as a regulatory approved imaging agent.”

The NOBLE Registry is being conducted at nine sites globally, with a site in Jakarta, Indonesia now added to the study. In addition to Australia and Indonesia, clinical sites are located in Egypt, India, Mexico, Nigeria, South Africa, Turkey, and the United Arab Emirates.

About the NOBLE Registry

The NOBLE Registry is led by Principal Investigator Dr. Batool Albalooshi, Head of Nuclear Medicine and Molecular Imaging at the Dubai Health Authority, United Arab Emirates, and is co-supported by Telix and the Brussels-based Oncidium Foundation. The NOBLE Registry will collect prospective, real-world clinical data on the use of TLX599-CDx from a consortium of sites in nine countries, including Australia.5 Each site will conduct its own investigator-initiated clinical study of TLX599-CDx under a common protocol and will share resulting data with the NOBLE Registry. Data collected will include use of TLX599-CDx for the diagnostic imaging of patients with prostate cancer, from initial disease staging in newly diagnosed patients, through to the later stages of advanced disease and potentially selection for PSMA-directed therapies. Telix anticipates that this real-world data will facilitate the design of future formal registration clinical trials of TLX599-CDx. For more information visit www.nobleregistry.org

About Telix Pharmaceuticals Limited

Telix is a 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, Switzerland, Japan, 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, Illuccix® (TLX591-CDx) for prostate cancer imaging, has been approved by the Australian Therapeutic Goods Administration (TGA), and accepted for filing by the U.S. FDA.6 Telix is also progressing marketing authorisation applications for Illuccix® in the European Union7 and Canada.8 With the exception of Illuccix in Australia, none of Telix’s products have received a marketing authorisation in any jurisdiction.

Telix Media Contact

Dr. Stewart Holmstrom
Telix Pharmaceuticals Limited
Director Corporate Communications
Email: [email protected]

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. None of the technologies or products described in this document have received a marketing authorisation in any jurisdiction. 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).

1 Positron Emission Tomography.
2 NCCN® Prostate Cancer Guidelines Update, Version 1.2022 – 10/09/21.
3 In 2021 there are an estimated 27,100 SPECT and 6,070 PET cameras installed worldwide (Source: MEDraysintell).
4 ASX disclosure 02/11/21.
5 Australia, Egypt, India, Indonesia, Mexico, Nigeria, South Africa, Turkey, United Arab Emirates.
6 ASX disclosure 24/11/20.
7 ASX disclosure 01/05/20.
8 ASX disclosure 16/12/20.

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