Celsion, a biotechnology company, has reported promising clinical results from its Phase I trial evaluating ThermoDox for the treatment of recurrent chest wall breast cancer.
The Phase I study is being conducted at Duke University Medical Center through a grant jointly sponsored by Celsion and the National Institutes of Health. This Phase I study is designed to determine the maximum tolerated dose of ThermoDox when used in combination with microwave hyperthermia to treat mastectomy patients with recurrent chest wall (RCW) breast cancer.
According to Celsion, 16 patients have been treated with ThermoDox at doses ranging from 20mg/sqm to 40mg/sqm. ThermoDox has demonstrated positive clinical activity in all of the evaluable patients, said Celsion.
Concurrent with the Duke Phase I study, Celsion has commenced a pivotal Phase I/II open-label trial for ThermoDox in the treatment of RCW breast cancer that is designed to measure durable local complete response at the tumor site. Celsion expects to enroll approximately 100 patients in the US and to complete the Phase I portion of the study in 2009.
Michael Tardugno, Celsion’s president and CEO, said: We are pleased that the oncology team at Duke University Medical Center fully supports the continued development of ThermoDox. We are grateful for their commitment to this important work and look forward to their participation in our ongoing Phase I/II pivotal study.
With our current cash balance and the June 2009 $15 million payment from Boston Scientific for the purchase of Celsion’s medical device assets, we believe that Celsion has the funds sufficient to fully enroll this important trial.