On July 6, 2015 Celsion reported positive interim data from its ongoing open-label Phase 2 DIGNITY Trial of ThermoDox in recurrent chest wall (RCW) breast cancer (Press release, Celsion, JUL 6, 2015, View Source [SID:1234506166]). The trial is designed to enroll up to 20 patients at several U.S. clinical sites and is evaluating ThermoDox in combination with mild hyperthermia. Of the 17 patients enrolled and treated, 13 were eligible for evaluation of efficacy. Based on data available to date, every patient experienced a clinical benefit of their highly refractory disease within the ThermoDox treatment field, with a local response rate of 69% observed in the 13 evaluable patients, notably five complete responses (CR), four partial responses (PR) and four patients with stable disease (SD). The Company will complete enrollment in the study in the third quarter of 2015.
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"We have observed durable local responses in two-thirds of the patients treated using ThermoDox in three clinical trials to-date, which is significant considering the fact that these patients present with highly resistant chest wall tumors that had progressed on multiple previous therapies, including chemotherapy, radiation and hormone therapy," noted Dr. Nicholas Borys, Celsion’s senior vice president and chief medical officer. "We are aggressively pursuing opportunities to expand this program into Europe through the EURO-DIGNITY trial in which we expect to treat our first patient very soon."
These data are consistent with previously published Phase 1 data for ThermoDox plus hyperthermia in RCW breast cancer. The two similarly designed Phase 1 studies enrolled patients with highly resistant tumors found on the chest wall and who had progressed on previous therapies. Of the 29 patients treated in the two trials, 23 were eligible for evaluation of efficacy. A local response rate of 61% was reported in 14 of the 23 evaluable patients, with five complete responses and nine partial responses. A Clinical Response Rate (CR+PR+SD) was observed in 87% of the evaluable patients.
"These extremely impressive data position us to successfully pursue and take advantage of promising opportunities to accelerate the development and commercialization of ThermoDox in RCW breast cancer patients as we turn our attention to Europe and the initiation of EURO-DIGNITY, a multi-center study designed to evaluate ThermoDox’s potential to locally control chest wall lesions in earlier stage patients," stated Michael H. Tardugno, Celsion’s chairman, president and CEO. "Together, through our partnership with myTomorrows and our Early Access Program, our goal is faster commercialization and near-term revenue benefitting patients who are in dire need of more rapid access to new and better options for the treatment of this aggressive form of breast cancer."
The EURO-DIGNITY trial will evaluate ThermoDox plus hyperthermia and radiation in earlier stage breast cancer patients and is designed to support a registration filing in Europe. This study will be conducted in five countries with the support of key European investigators and with assistance from MedLogics Corporation, a hyperthermia device company based in Italy. In addition, Celsion has a license and distribution agreement with myTomorrows to implement an Early Access Program (EAP) for ThermoDox in all countries of the European Union plus Switzerland for the treatment of patients with RCW breast cancer. The Company expects to have ThermoDox available in mid-2015 for sale at commercial prices to physicians who are treating patients with limited therapeutic options. The EAP provides physicians with access to products in later stage development that demonstrate evidence of clinical benefit with an acceptable safety profile and a quality manufacturing process in place.