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MELBOURNE, Australia, Sept. 28, 2022 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has approved a pivotal Phase III registration study that will bridge to Telix's global Phase III 'ZIRCON' trial of TLX250-CDx (89Zr-girentuximab), for the imaging of clear cell renal cell carcinoma (ccRCC) with position emission tomography (PET).
The investigational new drug (IND) application was submitted by Telix's partner in the Greater China region, Grand Pharmaceutical Group Limited (Grand Pharma). The bridging study is required to provide "supplementary" data obtained in a Chinese population to establish that the diagnostic efficacy of this investigational product is equivalent in Chinese and Western populations. A dosimetry study enrolling 10 patients will precede the multi-centre Phase III bridging study, which is expected to enrol 100 patients.
A successful outcome from Telix's global ZIRCON trial combined with positive data from this Phase III bridging study will support a future marketing authorisation application for TLX250-CDx in China.
Dr David N Cade, CEO Telix Asia Pacific, said "This IND is a significant milestone for Telix and our partner Grand Pharma, enabling us to proceed with a pivotal registration study and ultimately bring new options to the 73,000 people newly diagnosed with renal cell carcinoma in China each year where there is currently critical unmet medical need."
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" (IDRMs), typically identified based on computed tomography (CT) or magnetic resonance imaging (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,[1] reflecting the significant unmet clinical need to improve the diagnosis and staging of clear cell renal cell carcinoma (ccRCC), the most common and aggressive form of kidney cancer.
About the ZIRCON Study
ZIRCON (Zirconium Imaging in Renal Cancer Oncology, NCT03849118) is a confirmatory, prospective, open-label, multi-centre phase III study to evaluate sensitivity and specificity of 89Zr-TLX250-CDx PET/CT imaging to non-invasively detect clear cell renal cell cancer (ccRCC) in adult patients with "indeterminate renal masses" (IDRMs), scheduled for partial or total nephrectomy. The study completed enrolment in July 2022 and Telix expects to report study outcomes in 2H, 2022.[2]
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.
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] Telix is also progressing marketing authorisation applications for this investigational candidate in Europe[5] and Canada.[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 disclosure committee of Telix Pharmaceuticals Limited.
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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. You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the ASX or on our website.
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.
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[1] ASX disclosure 1 July 2020. |
[2] ASX disclosure 11 July 2022. |
[3] ASX disclosure 20 December 2021. |
[4] ASX disclosure 2 November 2021. |
[5] ASX disclosure 10 December 2021. |
[6] ASX disclosure 16 December 2020. |
