Celsion Announces Publication of the Study of ThermoDox® + Ultrasound, "TARDOX Study Protocol" in the Journal of Therapeutic Ultrasound
Presentation of TARDOX Study Phase I Findings at the Upcoming RSNA 2017 Annual Meeting
First Ever Study Evaluating ThermoDox® with
The article describes the clinical trial design for the TARDOX Study. 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 tumors.
- The primary outcome measures for the study was the direct quantification of the doxorubicin concentration before and after focused ultrasound (FUS) mediated hyperthermia from tumor biopsies, using high performance liquid chromatography (HPLC).
- The secondary outcome measures for the study relate to the safety and feasibility of inducing controlled FUS-mediated targeted hyperthermia in the target tumor non-invasively in order to achieve ThermoDox® release.
The TARDOX Study, which is supported by the
The Company also announced that an abstract for the TARDOX Study has been accepted for presentation at the
- The abstract, entitled "Clinical Results of a Phase I First in Man Study of Targeted Delivery of Lyso-thermosensitive Liposomal Doxorubicin by Extracorporeal Focused-Ultrasound Hyperthermia for Liver Tumours," will be presented by Dr.
Paul Lyonon Monday, November 27, 2017at 11:40 am(local time) during Vascular Interventional (10-Liver Cancer) Session - Room E352.
- The presentation will summarize clinical findings from all patients treated in the TARDOX Study, a Phase I clinical study of ThermoDox®,
Celsion'sheat-activated liposomal encapsulation of doxorubicin, in combination with focused ultrasound to treat primary and metastatic liver cancer.
Professor Constantin-C. Coussios, senior author and Director of the
Celsion's most advanced program is a heat-mediated, tumor-targeting drug delivery technology that employs a novel heat-sensitive liposome engineered to address a range of difficult-to-treat cancers. The first application of this platform is ThermoDox®, a lyso-thermosensitive liposomal doxorubicin (LTLD), whose novel mechanism of action delivers high concentrations of doxorubicin to a region targeted with the application of localized heat at 40°C, just above body temperature. In one of its most advanced applications, ThermoDox®, when combined with radiofrequency thermal ablation (RFA), has the potential to address a range of cancers. For example, RFA in combination with ThermoDox® has been shown to expand the "treatment zone" with a margin of highly concentrated chemotherapy when treating individual primary liver cancer lesions. The goal of this application is to significantly improve efficacy.
Celsion's LTLD technology leverages two mechanisms of tumor biology to deliver higher concentrations of drug directly to the tumor site. The first: Rapidly growing tumors have leaky vasculature, which is permeable to liposomes and enables their accumulation within tumors. Leaky vasculature influences a number of factors within the tumor, including the access of therapeutic agents to tumor cells. Administered intravenously, LTLD is engineered to allow significant accumulation of liposomes at the tumor site at the time of radiofrequency ablation as these liposomes recirculate in the blood stream. The second: When the tumor tissue is heated to a temperature of 40°C or greater, the heat-sensitive liposome rapidly changes structure and the liposomal membrane selectively dissolves, creating openings that release the chemotherapeutic agent directly into the tumor and into the surrounding vasculature. Drug concentration increases as a function of the accumulation of liposomes at the tumor site, but only where the heat is present. This method targets only the tumor and the area related to tumor invasion, supporting precise drug targeting.
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