Full Press Release Details
Melbourne (Australia) | 02 May 2024
Telix today announces that the first patient has been dosed in a named patient program in Austria for TLX250-CDx ( 89 Zr-DFO-girentuximab, Zircaix® 1 ). TLX250-CDx is the Company’s investigational non-invasive carbonic anhydrase IX (CAIX) targeting positron emission tomography (PET) imaging agent for clear cell renal cell carcinoma (ccRCC), the most common and aggressive form of kidney cancer.
The first patient was dosed at AKH Vienna (Vienna General Hospital) in Vienna, Austria. Through this named patient program (‘Heilversuch’), physicians may seek individual patient access to TLX250-CDx for use in PET characterisation of renal masses as ccRCC. This follows the completion of Telix’s successful global Phase III ZIRCON study ( Zi rconium in R enal C ancer On cology, ClinicalTrials.gov Identifier: NCT03849118 ), which reported positive results in November 2022, meeting all co-primary and secondary endpoints 2 .
Manuela Schmidinger, Professor of Medicine, and Program Director Renal Cell Carcinoma (RCC) at AKH, commented, “There is an urgent unmet medical need for new technologies that enable early detection of ccRCC, with invasive biopsy the standard of care, which can lead to complications and is often inconclusive. TLX250-CDx has demonstrated efficacy in clinical trials as a ‘Molecular Biopsy™’ and is now recognised in EAU Guidelines as an emerging technology for the management of RCC 3 . It is therefore extremely good news for patients that this Breakthrough diagnostic is available in Austria on a named patient basis.”
Frédéric Fantino, Telix Medical Director for the Europe, Middle East and Africa (EMEA) region added, “We are pleased to provide continued access to TLX250-CDx in Austria, in doing so broadening the European footprint for Telix’s global expanded access program. Based on clinical results, we believe this investigational agent has potential to change standard of care in the diagnosis of ccRCC as an accurate non-invasive imaging modality, similar to how PSMA-PET 4 is transforming the management of prostate cancer.”
The Austrian Medicinal Products Act (Arzneimittelgesetz, AMG) permits the use of a medicinal product in an individual patient prior to marketing authorisation and outside the context of a clinical trial in exceptional circumstances, as regulated by the Ministry of Health.
Telix has commenced the regulatory filing for TLX250-CDx (Zircaix® 1 ) with the U.S. Food and Drug Administration (FDA) under a Biologics License Application (BLA) rolling submission 5 and is progressing other equivalent applications with regulatory agencies in key commercial jurisdictions.
Physicians in Europe who may have eligible patients can email eap-emea@telixpharma.com for further information about TLX250-CDx named patient access. For more information about ongoing clinical trials of TLX250-CDx, please visit https://telixpharma.com/our-portfolio/clinical-trials/
Telix’s Policy on Offering Compassionate Use to Investigational Medicines can be downloaded at the following link .
TLX250-CDx has not received a marketing authorisation in any jurisdiction.
• Brand name subject to final regulatory approval. ↩︎
• Telix ASX disclosure 7 November 2022. ↩︎
• EAU Guidelines on Renal Cell Carcinoma (April 2024), available at: https://uroweb.org/guidelines/renal-cell-carcinoma . ↩︎
• Imaging of prostate-specific membrane antigen with positron emission tomography. ↩︎
• Telix ASX disclosure 19 December 2023. ↩︎