Good Early Results for Celsion Breast Cancer Drug

Celsion Corp. has presented combined clinical study results from the company’s Phase I study and the Duke University-sponsored Phase I trial of ThermoDox plus hyperthermia in Breast Cancer Recurrences at the Chest Wall (BCRCW). The results were presented at the 2013 San Antonio Breast Cancer Conference.  

The two similarly designed Phase I studies enrolled patients with highly resistant tumors found on the chest wall and who had progressed on previous therapy including chemotherapy, radiation therapy and hormone therapy. Unresectable BCRCW is very difficult to treat and often responds poorly to radiation and systemic chemotherapy.

ThermoDox in combination with mild hyperthermia was evaluated in these patients in as many as six cycles. Both studies employed an open label 3+3 dose escalation study design to determine the Maximum Tolerated Dose (MTD), evaluate safety and determine early effects of ThermoDox in combination with mild hyperthermia. There were 29 patients treated in the two trials (11 patients in the company’s study and 18 patients in the Duke study). Of the 29 patients treated, 23 were eligible for evaluation of efficacy. A local response rate of over 60% was reported in 14 of the 23 evaluable patients with five complete responses and nine partial responses. Based on the results from these two Phase I studies, Celsion is currently enrolling up to 20 patients in an open label Phase II study at five U.S. clinical sites.