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ZIRCON Phase III Kidney Cancer Imaging Study Completes Target Enrolment

ZIRCON Phase III Kidney Cancer Imaging Study Completes Target Enrolment GlobeNewswire March 07, 2022

MELBOURNE, Australia, March 08, 2022 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, “Telix”, the “Company”) today announces that ZIRCON (Zirconium in Renal Cancer Oncology, NCT03849118) a pivotal Phase III study of investigational renal (kidney) cancer imaging agent TLX250-CDx has dosed 252 patients, the target enrolment for the study. TLX250-CDx (89Zr-DFO-girentuximab) is an investigational product for the imaging of clear cell renal cell carcinoma (ccRCC) with position emission tomography (PET). TLX250-CDx has received “Breakthrough Designation” from the U.S. Food and Drug Administration (FDA).1

As permitted under the clinical study protocol, Telix will continue recruiting into the study for up to an additional three months. This additional recruitment will both generate further data in support of the Biologics License Application (BLA) and facilitate continued experience for trial sites ahead of Telix’s planned transition to opening a broader, more accessible Expanded Access Program (EAP). The EAP for TLX250-CDx is currently planned to commence in June 2022. Telix expects to report the outcome from the ZIRCON study in 2H, 2022.

Dr Colin Hayward, Telix’s Chief Medical Officer said, “We are pleased to have reached this important milestone in our Phase III program, and to have reached target enrolment. Recruitment into this study has accelerated as clinical sites have gradually re-opened due to COVID and investigators have become accustomed to using the imaging agent. We look forward to delivering the outcome of this highly innovative study with the goal of delivering an important unmet medical need.”

Dr Viraj Master, Director of Clinical Research, Department of Urology at Emory University School of Medicine added, “We congratulate Telix and the recruiting sites on completion of this important recruitment milestone. Clear cell renal cell carcinoma is the most common and aggressive form of kidney cancer. There is a clear need for a diagnostic tool that can aid in the management of the disease and better guide surgical decisions. In anticipation of study results, investigators at the sites have been excited by the potential utility of the agent in patients with indeterminate renal masses.”

About TLX250-CDx

TLX250-CDx (89Zr-girentuximab) is an investigational product being developed by Telix for the purpose of non-invasive detection of clear cell renal cancer in patients with “indeterminate renal masses” (IDMRs) are, typically identified based on CT or MRI imaging and are an increasing medical dilemma as more scans are performed and more IDRMs are identified. Girentuximab is a monoclonal antibody that targets carbonic anhydrase IX (CAIX), a cell surface target that is highly expressed in several human cancers including renal, lung and oesophageal cancers. In July 2020, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy (BT) designation for TLX250-CDx, reflecting the significant unmet clinical need to improve the diagnosis and staging of ccRCC, the most common and aggressive form of kidney cancer.

About the ZIRCON Study

ZIRCON (Zirconium Imaging in Renal Cancer Oncology, NCT03849118) is an international multicentre Phase III study at 34 sites in Europe, Australia, Turkey, Canada and the United States. ZIRCON is a prospective imaging trial in renal cancer patients undergoing kidney surgery with the objective of determining the sensitivity and specificity of TLX250-CDx PET imaging to detect clear cell renal cell cancer (ccRCC) in comparison with histologic “standard of truth” determined from surgical resection specimens.

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan, Switzerland, 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® (kit for preparation of gallium-68 (68Ga) gozetotide (also known as 68Ga PSMA-11) injection) for prostate cancer imaging, has been approved by the U.S. Food and Drug Administration (FDA),2 and by the Australian Therapeutic Goods Administration (TGA).3 Telix is also progressing marketing authorisation applications for this investigational candidate in Europe4 and Canada.5

Telix Media Contact

Dr. Stewart Holmstrom
Telix Pharmaceuticals Limited
Director Corporate Communications
Email: stewart.holmstrom@telixpharma.com

This announcement has been authorised for release by Dr. Christian Behrenbruch, Managing Director and Group Chief Executive Officer.

Legal Notices

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 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. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to publicly update or revise any forward-looking statements contained in this announcement, whether as a result of new information, future developments or a change in expectations or assumptions. The Telix Pharmaceuticals name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates (all rights reserved).

1 Telix ASX disclosure 1 July 2020.
2 ASX disclosure 20 December 2021.
3 ASX disclosure 2 November 2021.
4 ASX disclosure 10 December 2021.
5 ASX disclosure 16 December 2020.


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