Completion of Phase I Enrolment of Japanese Renal Cancer Study
Tokyo (Japan) – 27th October 2020. Telix Pharmaceuticals Japan K.K. is pleased to announce the completion of Phase I enrolment of the Company’s Phase I/II ZIRDAC-JP study of Telix’s renal cancer diagnostic imaging product TLX250-CDx (89Zr-girentuximab) in Japan.
Telix Pharmaceuticals Japan K.K., a wholly-owned subsidiary of Telix Pharmaceuticals Limited is pleased to announce the completion of Phase I enrolment of the Company’s Phase I/II ZIRDAC-JP study of Telix’s renal cancer diagnostic imaging product TLX250-CDx (89Zr-girentuximab) in Japan.
The ZIRDAC-JP study (Zirconium Dosing and Comparison in Japan) is a Japanese multi-centre Phase I/II study that will recruit approximately 40 patients in total. The objective of the Phase I component of the ZIRDAC-JP study is to comparatively evaluate the safety, tolerability, radiation dosimetry and pharmacokinetics / pharmacodynamics of TLX250-CDx in Japanese patients.
The patient population for the ZIRDAC-JP trial has been selected to be identical to Telix’s global Phase III ZIRCON trial, which is presently recruiting patients at 33 sites internationally and is expected to complete recruitment in Q1 2021. The ZIRDAC-JP study has been designed in consultation with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) to collect the necessary data to potentially bridge to the ZIRCON study, by confirming that dosing and pharmacology of TLX250-CDx in Japanese patients is equivalent to non-Japanese patients. Following data review and consultation with the PMDA, Telix expects to commence the Phase II component of the ZIRDAC-JP study in early 2021.
Telix Pharmaceuticals Japan K.K. President, Dr. Shintaro Nishimura stated, “The efficient completion of enrolment into the Phase I part of the ZIRDAC-JP study is a testament to the commitment of Dr Nakaigawa, the principal investigator and his team at Yokohama City University Hospital, and most importantly the patients who participated in this trial under COVID-19 conditions. This represents a significant milestone for Telix Japan and the broader Japanese nuclear medicine community. We now look forward commencing the Phase II part of the ZIRDAC-JP study and ultimately bringing this breakthrough kidney cancer imaging product to market in Japan in coordination with the global development for this asset.”
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TLX250-CDx does not have regulatory approval in any jurisdiction.