Date: 2015-07-06
Type of information: Interim results
phase: 2
Announcement: interim results
Company: Celsion (USA - NJ)
Product: ThermoDox® (encapsulated doxorubicin) in combination with mild hypothermia
Action
mechanism: antineoplastic agent. Using its LTSL (lysolipid thermally sensitive liposomes) technology, Celsion has encapsulated doxorubicin to create ThermoDox®. The heat-sensitive liposome rapidly changes structure when heated to a specific temperature, creating openings in the liposome which release doxorubicin directly into the targeted tumor. ThermoDox®, delivered by IV infusion, is designed to be used in combination with hyperthermic (heat-based) treatments, such as radiofrequency thermal ablation (RFA), microwave hyperthermia and high intensity focused ultrasound (HIFU). ThermoDox® leverages two mechanisms of tumor biology to deliver higher concentrations of drug directly to the targeted tumor site. First, tumors have leaky vasculature, which is permeable to liposomes and enables their accumulation within tumors. Second, when heated, blood vessels in tumors become even more permeable, further increasing the accumulation of liposomes in tumors before releasing the drug payload. The potential of this approach has been demonstrated in vivo; in animal models, ThermoDox® has been shown to deliver 25 times more doxorubicin than IV doxorubicin into tumors, and five times more doxorubicin than standard liposomal formulations of the drug.
Disease: recurrent chest wall (RCW) breast cancer
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: 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.
Latest
news: * On July 6, 2015, Celsion Corporation announced positive interim data from its ongoing open-label Phase 2 DIGNITY Trial of ThermoDox® in recurrent chest wall (RCW) breast cancer. 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. 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. 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.
