First Patients Dosed in Phase III ZIRCON Trial of Renal Cancer Imaging Product in Turkey
10/22/2020 | 01:00am EST
MELBOURNE, Australia and ISTANBUL, Turkey, Oct. 22, 2020 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’, the ‘Company’) and Eczacıbaşı-Monrol Nuclear Products Co. (‘Eczacıbaşı Monrol’) are pleased to announce that the first patients have been dosed in Telix’s Phase III ZIRCON clinical trial of Telix’s renal cancer diagnostic imaging product TLX250-CDx (89Zr-girentuximab) in Turkey.
The objective of the ZIRCON trial is to evaluate the sensitivity and specificity of PET/CT imaging with TLX250-CDx to non-invasively detect clear cell renal cell carcinoma (ccRCC) in patients with indeterminate renal masses in comparison with surgical resection (histology), as the standard of truth. Under a contract manufacturing agreement, Eczacıbaşı Monrol will supply 89Zr-labelled TLX250-CDx for the Turkish clinical sites.
The ZIRCON trial includes four participating clinical study sites in Turkey, comprising Istanbul Training and Research Hospital, Istanbul University-Cerrahpasa, Ankara Hacettepe University and Ankara University.1
Telix Chief Medical Officer, Dr Colin Hayward stated, “We are pleased to have commenced the Phase III ZIRCON clinical trial in Turkey and wish to acknowledge the team at Eczacıbaşı Monrol, as well as the principal investigators and study teams at each of the four institutions participating in the study, who have made this important milestone possible.”
Aydın Küçük, General Manager of Eczacıbaşı Monrol added, “As one of our missions is to contribute to the human health, we are very honoured to be part of this significant achievement of the ZIRCON clinical trial initiation in Turkey with the first patients’ doses manufactured at our Istanbul facility, and we are thankful to the Telix team for this great collaboration.”
About the ZIRCON Study
ZIRCON (“Zirconium Imaging in Renal Cancer Oncology”) is an international multi-centre Phase III study at 33 sites in Europe, Australia, Turkey, Canada and the United States (subject to regulatory approval in the various jurisdictions). ZIRCON is a prospective imaging trial in approximately 250 renal cancer patients undergoing kidney surgery, to determine the sensitivity and specificity of TLX250-CDx PET imaging to detect clear cell renal cell cancer (ccRCC) in comparison with histologic “ground truth” determined from surgical resection specimens.
About TLX250 / TLX250-CDx TLX250 (Girentuximab) is being developed by Telix Pharmaceuticals Limited both as a diagnostic PET imaging agent, 89Zr-Girentuximab (Phase III) and a therapeutic radiopharmaceutical, 177Lu-Girentuximab (Phase II). TLX250 is an antibody-based platform that targets carbonic anhydrase IX (CAIX), a cell surface target that is highly expressed in several human cancers including renal, lung and oesophageal cancer. High CAIX tumour expression is generally correlated with poor prognosis. Telix has prioritised the development of TLX250 for metastatic renal cell carcinoma (RCC), particularly the clear cell variant (ccRCC), which typically over-expresses CAIX.
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). Telix is headquartered in Melbourne, Australia 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 needs in prostate, renal and brain cancer. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit www.telixpharma.com.
About Eczacıbaşı Monrol
Eczacıbaşı Monrol Nuclear Products Co. is a leading developer, manufacturer and distributor of radiopharmaceutical products in the Balkans, Middle East, North Africa, Central and Eastern Europe. Eczacıbaşı Monrol exports to more than 40 countries worldwide and also has manufacturing sites and operational projects in different regions. The company produces radiopharmaceuticals used for diagnosis and treatment in its seven world-class production facilities with a total of 12 cyclotrons and two SPECT production lines, one SPECT EU release site employing modern and environmentally friendly technologies. Eczacıbaşı Monrol’s facilities are GMP certified, and the Gebze-Turkey, Romania, Bulgaria facilities also have EU GMP certificates. The company also has been operating cyclotrons in Kuwait, Iraq, Libya, Pakistan and has long term operational agreements with two centres in Turkey and one centre in Dubai. Eczacıbaşı Monrol is headquartered in Kavacık (a district of Istanbul, Turkey) and services regional nuclear medicine needs through 300 employees and more than 20 distributors, delivering high quality and customer-oriented service to nuclear medicine centres. For more information visit www.monrol.com