ShareCelsion Corporation has launched a clinical trial, supported by the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC), to study the effectiveness of combining cancer drug ThermoDox with focused ultrasound to treat a range of tumours, including liver cancer
The trial was announced on Monday (20 November) with the publication of the manuscript, “Clinical trial protocol for TARDOX: a phase I study to investigate the feasibility of targeted release of lyso-thermosensitive liposomal doxorubicin (ThermoDox®) using focused ultrasound in patients with liver tumours,” in the Journal of Therapeutic Ultrasound.
This proof of concept study was designed to demonstrate the safety and feasibility of targeted drug release and enhanced delivery of doxorubicin from thermally sensitive liposomes (ThermoDox®) triggered by mild hyperthermia, induced by focused ultrasound in primary and metastatic solid liver tumours.
The TARDOX Study, which is supported by the NIHR Oxford BRC, was carried out as a multidisciplinary collaboration between Celsion, the Oxford University Institute of Biomedical Engineering (Prof. Constantin Coussios), the Oncology Clinical Trials Office (OCTO) and the Oxford University Hospitals NHS Foundation Trust (Prof Fergus Gleeson, Radiology and Prof Mark Middleton, Oxford BRC Co-theme Lead for Cancer). The first author is Dr Paul Lyon, academic clinical fellow, Oxford University Hospitals NHS Foundation Trust.
The researchers believe that TARDOX, the ThermoDox®/Focused Ultrasound trial, is an important step in demonstrating that ultrasound-induced hyperthermia can enable the highly targeted and non-invasive delivery of chemotherapeutic agents to tumours.
Read more here.