First Patients Dosed in Phase III ZIRCON Trial of Renal Cancer Imaging Product in Turkey
Melbourne (Australia) and Istanbul (Turkey) – 22nd October 2020. Telix and Eczacıbaşı-Monrol Nuclear Products Co. are pleased to announce that the first patients have been dosed in Telix’s Phase III ZIRCON clinical trial
Telix Pharmaceuticals and Eczacıbaşı-Monrol Nuclear Products Co. 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.
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.”
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TLX250-CDx does not have regulatory approval in any jurisdiction.