MELBOURNE, Australia, June 27, 2023 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces further details of the positive results from its completed pivotal Phase III ZIRCON study of TLX250-CDx (⁸⁹Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC) (ClinicalTrials.gov Identifier: NCT03849118).

New data demonstrates the ability of TLX250-CDx to detect extrarenal lesions, supporting potential clinical utility in the metastatic or recurrent setting, and for staging and informing treatment decisions.

TLX250-CDx PET/CT detected more lesions in liver and bone than diagnostic CT imaging alone. This reinforces the performance of this investigational diagnostic imaging agent across all analyses, with previously presented data showing an excellent overall sensitivity and specificity of 86% and 87%, respectively, together with high intra-reader agreement.^{[1], [2]}

The results were featured in an oral presentation delivered on Monday, 26 June 2023 (CDT) by Jeremie Calais, MD, Director of the Clinical Research Program of the Ahmanson Translational Theranostics Division of the Department of Molecular and Medical Pharmacology at University of California, Los Angeles (UCLA), and a principal investigator in the Phase III ZIRCON study, at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2023 Annual Meeting in Chicago.

New data presented:

• 25 patients had ≥1 extrarenal lesions detected by whole body PET/CT (n=10), abdominal PET/CT (n=17), or both modalities (n=2)
• Extrarenal lesions were mostly localised in bone, liver, lung, adrenal glands and lymph nodes

Jeremie Calais, MD commented, "It is a pleasure to be showcasing further results from Telix's highly successful Phase III ZIRCON study at SNMMI, the premier educational, scientific, research, and networking event in nuclear medicine and molecular imaging worldwide. Data presented here in Chicago on extrarenal lesions demonstrates potential utility of TLX250-CDx for staging and monitoring high risk patients where there is a great deal of interest from the clinician community."

Telix is in the process of implementing an expanded access program in the United States and establishing named patient programs for TLX250-CDx in Europe.

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals. Telix is headquartered in Melbourne, Australia with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical-stage products that aims to address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX).

Visit www.telixpharma.com for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on Twitter (@TelixPharma) and LinkedIn.

TLX250-CDx has not received a marketing authorisation in any jurisdiction. Telix's lead product, gallium-68 (⁶⁸Ga) gozetotide (also known as ⁶⁸Ga PSMA-11) injection, has been approved by the U.S. Food and Drug Administration (FDA),^[3] and by the Australian Therapeutic Goods Administration (TGA),^[4] and by Health Canada.^[5] Telix is also progressing marketing authorisation applications for this investigational candidate in the United Kingdom and the European Union.^[6]

Telix Investor Relations

Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Corporate Communications and Investor Relations
Email: kyahn.williamson@telixpharma.com

Legal Notices

This announcement is not intended as promotion or advertising directed to any healthcare professional or other audience in any country worldwide (including Australia, United States and the United Kingdom). This announcement may include forward-looking statements that relate to anticipated future events, financial performance, plans, strategies or business developments.  Forward-looking statements can generally be identified by the use of words such as "may", "expect", "intend", "plan", "estimate", "anticipate", "outlook", "forecast" and "guidance", or other similar words. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on the Company's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect the Company's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix's business, forward-looking statements may include, but are not limited to, statements аbout: the initiation, timing, progress and results of Telix's preclinical and clinical studies, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities; the commercialisation of Telix's product candidates, if or when they have been approved; estimates of Telix's expenses, future revenues and capital requirements; Telix's financial performance; developments relating to Telix's competitors and industry; and the pricing and reimbursement of Telix's product candidates, if and after they have been approved. Telix's actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements.

Except as required by applicable laws or regulations, Telix does not undertake to publicly update or review any forward-looking statements. Past performance cannot be relied on as a guide to future performance. Readers should read this announcement together with our material risks, as disclosed in our most recently filed reports with the ASX and on our website.

©2023 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals and Illuccix name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates (all rights reserved).

[1] Top line data released to ASX on 7 November 2022.

[2] Telix media release 20 February 2023.

[3] Telix ASX disclosure 20 December 2021.

[4] Telix ASX disclosure 2 November 2021.

[5] Telix ASX disclosure 14 October 2022.

[6] Telix ASX disclosure 3 April 2023.

 

Source: Telix Pharmaceuticals Limited Related Stocks: Australia:TLX