Japanese Renal Cancer Imaging Trial Meets Study Objectives
Melbourne (Australia) and Kyoto (Japan) – 21 April 2021. Telix announces the Company’s ZIRDAC-JP study of its renal cancer imaging product demonstrates safety and tolerability in Japanese patients.
Telix is pleased to announce that the Phase I component of the Company’s Phase I/II ‘ZIRDAC-JP’ clinical study of its renal cancer imaging product has reported results and met the study objectives, demonstrating safety and tolerability of TLX250-CDx (89Zr-girentuximab) in Japanese patients.
The ZIRDAC-JP study (Zirconium Dosing and Comparison in Japan) is a Japanese Phase I/II study to evaluate the safety, tolerability, radiation dosimetry and pharmacokinetics of TLX250-CDx in Japanese patients. The Phase I component of the ZIRDAC-JP study was conducted at Yokohama City University Hospital in Yokohama, Japan and all data were reviewed by the study’s independent Data and Safety Monitoring Board (DSMB). In total, six patients with an indeterminate renal mass identified on pre-study CT or MRI imaging were enrolled from August to November 2020. All patients underwent dosing with TLX250-CDx followed by multi-timepoint positron emission tomography (PET) imaging. All enrolled patients completed the study.
No adverse events (AEs) or serious adverse events (SAEs) were observed in any of the study patients. The whole-body and organ-specific radiation dosimetry of TLX250-CDx demonstrated no difference between Japanese and Caucasian patient populations. The pharmacology of TLX250-CDx in Japanese patients was comparable to that of previous studies reported in other patient ethnic groups.
Telix Chief Medical Officer Dr. Colin Hayward stated, “We are highly encouraged by both the safety and tolerability profile, as well as the comparability of the dosing and pharmacology of TLX250-CDx between Japanese and Caucasian patient populations. We now plan to consult with the Japanese regulator to confirm the design of the next stage of development for TLX250-CDx, with the objective of bridging to Telix’s international Phase III ZIRCON study, currently enrolling patients at 36 sites globally. We wish to express our appreciation to the study’s principal investigator at Yokohama City University Hospital, Dr. Nakaigawa, his research team and the patients who participated in this study.”
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