PR NewsWire | Mar 14 2023
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MELBOURNE, Australia, March 14, 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).1
The results were featured in a "Game Changing" oral session delivered by Professor Dr. Peter Mulders from Radboud University Medical Centre (Netherlands), a ZIRCON Principal Investigator, at the 38th Annual European Association of Urology (EAU) Congress, on Saturday, 11 March 2023.
Game Changing sessions are reserved for Phase III trials or other developments that the EAU’s Scientific Congress Office believes will have a large impact on daily practice.
New data presented:
- TLX250-CDx demonstrated a high degree of consistency between readers with a very high sensitivity (85.5%) and specificity (87.0%) overall, and 85.5% / 89.5% for small masses (<4cm), confirming optimal SUVmax thresholds for image interpretation;
- The correlation of CAIX expression on histology with imaging results.
Professor Dr. Peter Mulders commented, "I’m delighted to be at EAU, the leading urological event in Europe, sharing further detailed results from Telix’s Phase III ZIRCON study with the medical community. New data reinforces the clinical potential of this investigational agent, even in small renal masses which are most prevalent and present the highest diagnostic challenge, with remarkable consistency across readers. On behalf of Telix, I’d like to thank all the European sites and patients for their participation in this ground-breaking study."
Telix is in the process of establishing expanded access studies and supporting named patient programs for TLX250-CDx in the United States and 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). For more information visit www.telixpharma.com and 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),2 and by the Australian Therapeutic Goods Administration (TGA),3 and by Health Canada.4
Telix Investor Relations
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Corporate Communications and Investor Relations
Email: kyahn.williamson@telixpharma.com
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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 about: 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.
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1 Top line data released to ASX on 7 November 2022.
2 ASX disclosure 20 December 2021.
3 ASX disclosure 2 November 2021.
4 ASX disclosure 14 October 2022.