Celsion Corporation has enrolled the first patient in its randomised Phase II study of ThermoDox, a heat-activated liposomal encapsulation of doxorubicin, plus radiofrequency ablation (RFA), used as a treatment for colorectal liver metastases (CRLM).
ThermoDox is a frequently used oncology drug for the treatment of a wide range of cancers.
The multicentre Phase II study will randomise around 88 patients with colorectal cancer to receive either RFA in combination with ThermoDox or RFA alone for the treatment of liver tumours.
The primary study endpoint is based on one-year local tumour recurrence, with secondary endpoints of time to progression and overall survival.
"Adding ThermoDox to RFA as adjuvant therapy is a combination which has demonstrated early clinical promise in treating larger tumours and multifocal disease. I look forward to understanding ThermoDox’s promise in this larger outcome study," said Dr. Steven K. Libutti, lead principal investigator for the study.
"Addressing these metastases allows us to improve three and five-year survival rates among patients with this aggressive disease. While RFA can be effective in treating these tumours, it is often limited to smaller metastases within the liver," Libutti added.
In an earlier Phase I dose escalation study ThermoDox, in combination with RFA, showed tolerability and a dose response relationship.
Celsion president and CEO Michael H. Tardugno said the company has successfully completed the interim efficacy analysis of the Phase III HEAT study of ThermoDox in primary liver cancer.
"We look forward to the results of this trial around the time ThermoDox approaches registration, following a positive outcome in the HEAT study," Tardugno added.
Celsion aims to develop and commercialise cancer drugs including tumour-targeting treatments using focused heat energy in combination with its heat-activated liposomal drug technology.
The heat-activated liposomal drug delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumour.