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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About Telix Pharmaceuticals Limited (ASX: TLX)
Telix is a late-stage radiopharmaceutical company developing a broad portfolio of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix’s products address significant unmet medical needs in prostate, kidney, glioblastoma (brain) and hematologic (blood) cancers, as well as a range of immunologic and high value rare diseases.
The Company is headquartered in Melbourne, Australia with international operations in Belgium, Japan, and the United States, and is listed on the Australian Securities Exchange (ASX: TLX).
Telix’s lead product, Illuccix® (TLX591-CDx) for prostate cancer imaging, has been accepted for filing by the U.S. Food and Drug Administration (FDA) and has been granted Priority Review status by the Australian Therapeutic Goods Administration (TGA). Telix is also progressing marketing authorisation applications for Illuccix® in the European Union and Canada. None of Telix’s products have currently received a marketing authorisation in any jurisdiction. For more information visit www.telixpharma.com and follow Telix on Twitter (@TelixPharma) and LinkedIn.