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news.Celsion Corporation has announced that the first patient has been enrolled in a Phase II study of its ThermoDox in combination with radiofrequency ablation (RFA).
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ThermoDox is a proprietary heat-activated liposomal encapsulation of doxorubicin, used for the treatment of colorectal liver metastases (CRLM).
The randomized multicenter Phase II study is anticipated to enroll up to 88 patients with colorectal cancer metastasized to the liver.
In the trial, patients will be randomized to receive either RFA plus ThermoDox or RFA alone for the treatment of their liver tumors.
The primary objective of the study is one year local tumor recurrence, while secondary endpoints include time to progression and overall survival.
Celsion president and CEO Michael H Tardugno said the company’s Phase III HEAT study of ThermoDox in primary liver cancer has successfully completed its interim efficacy analysis.
"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.
The previous Phase I dose escalation study has reported tolerability and a significant dose response relationship of ThermoDox plus RFA.