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).
- 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.”
To read the full ASX disclosure please click here.
To return to Telix’s homepage please click here.
Second Industry Body Updates Guidance for Use of PSMA PET Imaging
Melbourne (Australia) and Indianapolis, IN (U.S.A.) – 21 September 2021. Telix welcomes SNMMI updated Appropriate Use Criteria for PSMA PET...
Telix at AdMeTech Summit on Precision Diagnosis and Treatment of Prostate Cancer
16 September 2021 – Clinical Spotlight | Telix to support and participate in AdMeTech 5th Global Summit on Precision Diagnosis...
NCCN Guidelines Updated to Include PSMA-PET Imaging
Melbourne (Australia) and Indianapolis, IN (U.S.A.) – 14 September 2021. Telix welcomes the updated NCCN Guidelines® for prostate cancer, which includes...
FDA Approves Phase II Kidney Cancer Therapy Study
Melbourne (Australia) and Indianapolis, IN (U.S.A.) – 14 September 2021. Telix announces the FDA has accepted the IND Application to...
Telix and Radius Sign Italian Distribution Agreement for Prostate Cancer Imaging
Melbourne (Australia) and Bologna (Italy) – 13 September 2021. Telix enters a commercial distribution agreement with Radius for Telix’s prostate...
Japanese Prostate Cancer Imaging Study Completes Enrolment
Melbourne (Australia) and Kyoto (Japan) – 9 September 2021. Telix has completed a Phase I clinical trial of TLX591-CDx for...
Telix to Collaborate with Kettering Health on Diagnostic PSMA Imaging & Targeting Theranostics
Melbourne (Australia), Indianapolis (IN, U.S.A.), and Kettering (OH, U.S.A.) – 7 September 2021. Telix announces collaboration with Kettering Health on...
Telix and Lightpoint Medical to Collaborate on Radioguided Surgery
Melbourne (Australia) – 23 August 2021. Telix announces collaboration with Lightpoint Medical to explore molecularly targeted radiation and Lightpoint SENSEI®...
Telix Half-Year Results 2021 and Company Update Conference Call
Melbourne (Australia) – 19 August 2021. Telix announces Half-Year Results 2021 and provides shareholder update
Telix Expands Prostate Cancer Activity with GenesisCare Collaboration
Melbourne (Australia) – 19 August 2021. Telix releases details of two ancillary studies under the ProstACT program, including a Phase...
Telix and Merck to Commence Pan-Cancer Clinical Combination Studies
Melbourne (Australia) – 18 August 2021. Telix announces pan-cancer clinical collaboration with Merck KGaA, Darmstadt, Germany.
Two New Studies to Explore Telix Assets in Breast Cancer Theranostics
Melbourne (Australia) – 18 August 2021. Telix announces two new studies to evaluate the potential utility of TLX591-CDx and TLX250-CDx...
Telix Progresses Novel Lung and Ovarian Cancer Theranostic APOMAB®
Melbourne and Adelaide (Australia) – 17 August 2021. Telix extends partnership with AusHealth relating to APOMAB®, a novel theranostic being...
Telix’s TLX66 in Phase II Academic Study of Pediatric Leukemia
Melbourne (Australia) and London (United Kingdom) – 17 August 2021. Telix announces Phase II academic study of TLX66 in children...
Telix H1 2021 Results and Company Update Conference Call
Melbourne (Australia) – 11 August 2021. Telix to hold investor conference call to present H1 2021 financial results and Company...
First Patient Dosed in CUPID Study of Telix’s Targeted Alpha Therapy Candidate for Prostate Cancer
Melbourne (Australia) – 5 August 2021. Telix announces the first patient has been dosed in its ‘CUPID’ Phase I study...
Ms. Helen Hovenga Joins Telix as Chief People Officer
4 August 2021 – Corporate Spotlight | Telix announces the appointment of Ms. Helen Hovenga in the role of Chief...
Telix Seneffe Production Facility: Progress Update
Melbourne (Australia) and Seneffe (Belgium) – 30 July 2021. Telix authorised to decommission first of two cyclotrons at Seneffe radiopharmaceutical...
Activities Report and Appendix 4C for June 2021 Quarter
Melbourne (Australia) – 22 July 2021. Telix provides its Appendix 4C and accompanying Activities Report for the quarter ended 30 June...
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...
Telix Appoints Gabrielle Wermenbol as Chief Financial Officer, EMEA
19 July 2021 – Corporate Spotlight | Gabrielle Wermenbol joins Telix as Chief Financial Officer, Europe, Middle East & Africa...
Kyahn Williamson Joins Telix to Lead Corporate Communications and Investor Relations
Melbourne (Australia) – 12 July 2021. Telix announces that Ms. Kyahn Williamson has joined the Telix executive leadership team in...
First Patient Dosed in Clinical Study of TLX250-CDx in Bladder Cancer
Melbourne (Australia) – 23 June 2021. Telix announces that a first patient has been dosed in a Phase I study...
IPAX-1 (TLX101 for Glioblastoma Therapy) Clinical Trial Update
Melbourne (Australia) – 21 June 2021. Telix announces preliminary safety data from the IPAX-1 Ph I/II study, with a follow-on...
Telix Update on FDA New Drug Application Review for Illuccix®
Melbourne (Australia) and Indianapolis, IN (U.S.A.) – 17 June 2021. Telix announces participation in a late-cycle meeting with the U.S....
Telix Pharmaceuticals and Applied Radiology launch TelixU Medical Education Platform Focused on Radiopharmaceutical Research
MELBOURNE, Australia and INDIANAPOLIS 14 June, 2021 – Telix announces the launch of a new educational platform focused on radiopharmaceutical...
Telix launches “Gallium Wave” Awareness Website
Melbourne (Australia) and Indianapolis (U.S.A.) – 11 June 2021. Telix announces the launch of a new website “Gallium Wave”, as...
Scott Law joins Telix as SVP Global Manufacturing Operations
11 June 2021 – Corporate Spotlight | Scott Law joins Telix as Senior Vice President Global Manufacturing Operations
Telix and ATS Awarded $1.56M ‘Eurostars’ Grant for Alpha Therapy
Liège (Belgium) and Gothenburg (Sweden) – 7 June 2021. Advanced Nuclear Medicine Ingredients S.A, a wholly owned European subsidiary of...