Launch of the International NOBLE Registry of Telix’s SPECT-Based Prostate Cancer Imaging Agent

Melbourne (Australia) and Brussels (Belgium) – 19 April 2021. Telix announces the launch of the international NOBLE Registry of Telix’s ‘rest of world’ prostate cancer imaging agent and the dosing of the first patient.

Telix is delighted to announce the launch of the international NOBLE Registry of Telix’s ‘rest of world’ prostate cancer imaging agent TLX599-CDx (^99mTc-HYNIC-iPSMA), and the dosing of the first patient at the University College Hospital, Ibadan (Nigeria).

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The aim of the NOBLE (Nobody Left Behind) Registry is to collect data on the clinical use of TLX599-CDx, a ‘sibling’ asset to Illuccix^® (TLX591-CDx, Kit for the preparation of ⁶⁸Ga-PSMA-11 injection). TLX599-CDx is an investigational product being developed by Telix to facilitate patient access to advanced prostate cancer imaging in countries where single photon emission computed tomography (SPECT) imaging is predominant in healthcare facilities. Whereas Illuccix^® utilises positron emission tomography (PET), TLX599-CDx employs SPECT, a diagnostic imaging technology that is widely available in healthcare facilities throughout the world.

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 eight countries, including Australia.

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. Telix anticipates that this real-world data will facilitate the design of future formal registration clinical trials of TLX599-CDx.

Telix Chief Executive Officer Dr. Christian Behrenbruch stated, “We are honoured to support the launch of the NOBLE Registry, which represents the very essence of our belief that every patient deserves access to the benefits of nuclear medicine. Telix is committed to providing access to advanced prostate cancer imaging to all men across the globe and it is fitting that this excellent technology, developed at the Instituto Nacional de Investigaciones Nucleares (ININ, Mexico), will play a part in delivering this objective. We wish to thank the Oncidium Foundation for their support and partnership, as well as the expert global clinical leadership team led by Dr. Albalooshi. Above all, we are grateful to the patients that will make this registry study possible and, in doing so, help to deliver an important milestone toward improving access to this important technology.”

NOBLE Registry committee Chair Dr. Batool Albalooshi said, “The advancement of PSMA directed diagnostics and therapeutics in prostate cancer is helping to extend life and improve treatment outcomes in men with prostate cancer. However, millions of men do not have access to PET imaging. For this reason, it is our aspiration to develop a powerful, affordable, and widely available alternative imaging tool by using iPSMA-SPECT technology.”

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About Telix Pharmaceuticals Limited (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.

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