(ASX:TLX) has announced that the last patient has been imaged in a phase one clinical study of the company’s investigational prostate cancer imaging product TLX591-CDx (Illuccix, Kit for the preparation of 68Ga-PSMA-11 injection).
The study is being conducted in collaboration with Kanazawa University.
This study, which has reached the target enrolment of ten patients, is the first clinical evaluation of a Gallium68-labeled prostate cancer diagnostic imaging agent in Japan.
The objective is to obtain safety data in a representative Japanese patient population and to confirm that the targeting and biodistribution of TLX591-CDx in patients are consistent with international experience.
The company said subject to positive outcomes, clinical data obtained from the study will facilitate development planning with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and potentially other Asian regulators.
According to Professor Atsushi Mizokami from the Department of Integrative Cancer Therapy and Urology, Kanazawa University, Graduate School of Medical Science, “I am pleased that we have successfully completed enrolment of the first Japanese clinical study of 68Ga-PSMA-11 for men with advanced prostate cancer, despite severe ongoing disruption caused by the COVID-19 pandemic. This state-of-the-art PET imaging agent is currently under regulatory review in 17 countries worldwide and we are excited to play our role in bringing this important new diagnostic tool to market in Japan as efficiently as possible.”
Shintaro Nishimura, President of Telix Pharmaceuticals Japan, added, “We are grateful to Professor Mizokami and his colleagues for their efforts in recruiting this trial in a timely fashion, as well as study participants for their commitment to delivering innovative benefits to Japanese men living with prostate cancer. I believe that this will become a cornerstone moment for future prostate cancer theranostics in Japan and the Asia-Pacific region and provides a pathway for Telix to engage with regulators for approval of our lead product, in Japan.”
