MELBOURNE, Australia, May 1, 2023 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces additional 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).

The results were featured in a late-breaking oral presentation delivered on Sunday, 30 April 2023 (CST) by Associate Professor Brian Shuch, MD, Director, Kidney Cancer Program, UCLA Institute of Urologic Oncology (Los Angeles, California) and a principal investigator in the Phase III ZIRCON study, at the American Urological Association's (AUA) Annual Meeting in Chicago. 

New data presented demonstrates the high value of TLX250-CDx PET/CT imaging in detecting ccRCC, with secondary analysis confirming utility and effectiveness in very small renal masses, which are prevalent and present a significant diagnostic challenge. 

In very small renal lesions (≤2cm, a secondary endpoint), sensitivity was 84% for all three readers, with specificity 92.3% to 100%. This reinforces the accuracy of this investigational diagnostic imaging agent across all analyses, with previously presented data showing an overall sensitivity and specificity of 86% and 87%, respectively.^1,2

Dr Colin Hayward, Chief Medical Officer at Telix stated, "The excellent sensitivity and specificity for small lesions considerably expands the clinical utility and potentially the commercial opportunity for TLX250-CDx. We expect that the ability to diagnose even very small lesions as ccRCC will be an important factor in driving market adoption, subject to product approval."

Associate Professor Brian Shuch, MD commented, "It is a great pleasure to be showcasing new data from Telix's Phase III ZIRCON study at AUA, the largest gathering of urologists in the world. We now have analyses on the outcome for very small renal masses, where the data set still shows outstanding sensitivity and specificity, far exceeding confirmatory trial success targets. This data is meaningful for surgeons to help them improve management by aiding risk stratification, selecting appropriate patients for treatment or in those where further imaging/biopsy could be indicated."

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 a marketing authorisation application 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

This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board.

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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