Telix Pharmaceuticals (ASX:TLX), an Australian biopharmaceutical company focused on the development of diagnostic and therapeutic products based on targeted radiopharmaceuticals or 'molecularly- targeted radiation', has filed to initiate a Phase 3 trial in Europe for 89Zr-DFO-girentuximab (TLX250) for the imaging of kidney cancer with Positron Emission Tomography (PET).
The ZIRCON study will be a global multi-center Phase 3 study with at least 15 sites in Europe, Australia and the United States, subject to regulatory approval in the various jurisdictions.
ZIRCON is a prospective imaging study in approximately 250 kidney cancer patients undergoing kidney surgery. It will determine the sensitivity and specificity of TLX250 PET imaging to detect clear cell renal cell cancer (ccRCC) in comparison with histologic 'ground truth' determined from surgical resection specimens.
According to Telix CEO Dr Christian Behrenbruch, “The filing of this clinical trial in Europe marks a major operational milestone for the Company in terms of realizing the value of our product pipeline. We would like to express our sincere appreciation to our partner, Heidelberg Pharma, for their extensive and practical support over the last 18 months with respect to getting this program launched, as well as our academic collaborators in the US, Australia and Europe.”
Telix chief medical officer Dr Andreas Kluge noted, “It has been a major undertaking by the Telix team to build the manufacturing network and clinical infrastructure to support this trial, particularly given the production complexity of radioactive drugs. With this initial filing in Europe, the Company will be focused on adding sites, including in Australia and the US in the coming months. We look forward to keeping shareholders closely informed of our progress.”