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Telix Pharmaceuticals Ltd — Capital/Financing Update 2019
Dec 23, 2019
31324_rns_2019-12-23_675a7101-521b-4364-b765-4db23f9ba450.pdf
Capital/Financing Update
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Telix Pharmaceuticals Limited ACN 616 620 369 Suite 401, 55 Flemington Road North Melbourne Victoria, 3051 Australia
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ZIRCON Phase 3 IND Submitted to the US FDA
Melbourne (Australia) – 24[th] December 2019 . Telix Pharmaceuticals Limited (ASX: TLX), has today announced that it has submitted a Phase 3 Investigational New Drug (IND) application to the United States Food and Drug Administration for TLX250-CDx ([89] Zr-girentuximab, for the imaging of renal cancer with Position Emission Tomography) as part of the international Phase 3 ZIRCON study. The ZIRCON study is expected to commence enrolling US patients in Q1 2020.[1]
Telix CEO Dr. Christian Behrenbruch said, “Nineteen sites in Europe and Australia are currently enrolling patients into the ZIRCON study. The planned addition of 6 US cancer centres to recruit at least 50 US patients will enable the study to be fully recruited 1H-2020.”
About TLX250-CDx ([89] Zr-girentuximab)
TLX250-CDx is an antibody-based imaging agent for use with Positron Emission Tomography (PET). TLX250-CDx targets a cell surface antigen called Carbonic Anhydrase IX (CAIX) which is expressed on the vast majority of clear cell renal cell cancers (ccRCC). ccRCC is the most common form of renal (kidney) cancer. CAIX is also highly expressed in many other cancers with poor prognosis, such as pancreatic, bladder, colorectal and lung cancers. In addition to developing TLX250-CDx to image CAIX-expressing cancers, Telix is also developing TLX250 ([177] Lu-girentuximab) for the treatment of CAIX-expressing cancers.
About ZIRCON
ZIRCON (Zirconium Imaging in Renal Cancer Oncology) is an international, confirmatory Phase 3 trial for the imaging of ccRCC using TLX250-CDx with PET. The trial will recruit approximately 250 patients and compares PET imaging with histology findings from the surgically resected tumour.
About Telix Pharmaceuticals Limited
Telix is a clinical-stage biopharmaceutical company focused on the development of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). The company is headquartered in Melbourne with international operations in Belgium, Japan and the United States. Telix is developing a portfolio of clinical-stage oncology products that address significant unmet medical need in renal, prostate and brain cancer. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit www.telixpharma.com.
Telix Corporate Contact
Telix Investor Relations
Dr Christian Behrenbruch Dr David N. Cade Telix Pharmaceuticals Limited Telix Pharmaceuticals Limited CEO CBO and Head of Investor Relations Email: [email protected] Email: [email protected]
1 Subject to FDA approval
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Important Information
This announcement does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States, or in any other jurisdiction in which such an offer would be illegal. The securities referred to herein have not been and will not be registered under the United States Securities Act of 1933 (the “US Securities Act”), or under the securities laws of any state or other jurisdiction of the United States and may not be offered or sold within the United States, unless the securities have been registered under the US Securities Act or an exemption from the registration requirements of the US Securities Act is available. None of the technologies or products described in this document have received a marketing authorisation in any jurisdiction. This announcement has been authorised for release by Dr Christian Behrenbruch, Managing Director and Chief Executive Officer.
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