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ZIRCON Phase 3 Renal Cancer Imaging Study: Progress Update

Melbourne (Australia) – 20 July 2021. Progress update on the ZIRCON Phase 3 study for the imaging of renal cancer with Positron Emission Tomography (PET).

Telix is pleased to provide an update on the progress of the ZIRCON Phase 3 study for the imaging of renal cancer with Positron Emission Tomography (PET).

Key Points:

  • ZIRCON is a Phase 3 pivotal study of 89Zr-DFO-girentuximab (TLX250-CDx), an investigational product for the imaging of clear cell renal cell carcinoma (ccRCC) with PET
  • ZIRCON is being actively recruited at 34 sites in the EU, Turkey, Australia, US and Canada
  • Study has exceeded 50% recruitment with a total planned recruitment of 252 patients
  • Recruitment hiatus due to COVID-19 has abated in most study territories with an increasingly predictable rate of patient enrolment into the study
  • Indicative recruitment rate (globally) is between 5 and 10 patients / week
  • TLX250-CDx has been granted FDA Breakthrough Therapy designation in the United States, which could potentially grant it an expedited review process.

ZIRCON is a 252 patient Phase 3 pivotal study, currently being conducted at 34 sites globally. The study has exceeded 50% recruitment despite significantly reduced recruitment over the last 12 months due to a pandemic operating environment. With at least 80% of sites in the study back recruiting into clinical trials, recruitment has significantly accelerated and indicative patient recruitment is 5-10 patients per week.

TLX250-CDx drug product for the ZIRCON trial is provided from Telix’s manufacturing and dispensing sites in Canada, United States, Turkey and the Netherlands. Transportation and logistics have also largely enabled a resumption to normal drug product delivery schedules, including to Australia. The company expects the trial to complete recruitment in the next 4-5 months, subject to ongoing pandemic conditions. Telix expects to commence the FDA Biologics License Application (BLA) consultation process before end-calendar year, as planned. A Japanese bridging study to ZIRCON has also been successfully completed.

Telix Chief Medical Officer Dr Colin Hayward noted, “It’s very pleasing to see the acceleration in the ZIRCON trial, having exceeded the half-way point of the study and a resumption to somewhat more normal clinical operating conditions. The feedback we are receiving from investigators is very positive and the company remains on track to achieve its stated objective of completing the trial this year, thus progressing a second FDA marketing authorisation submission after the Illuccix® prostate cancer imaging program.”

Dr Brian Shuch, Director of the UCLA Kidney Cancer Program and the Alvin & Carrie Meinhardt Endowed Chair in Kidney Cancer Research added, “Having an imaging agent that will predict clear cell kidney cancer prior to treatment will likely spare unnecessary biopsies and limit unnecessary surgeries. We hope that future studies will show this technology can improve our ability to accurately stage kidney cancer and perhaps allow better selection of patients for adjuvant therapy.”

Telix Chief Executive Officer Dr Christian Behrenbruch commented, “TLX250-CDx reinforces Telix’s innovation leadership position in urologic oncology and it’s exciting to see a second product heading down the final pathway towards commercialisation. Our clinical team and CROs have had to work extremely creatively to maintain the momentum of the study and we are grateful to our global investigators and patients, who have gone above and beyond to ensure the success of the study.”

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