Celsion Corp. (CLSN) Thursday said data from two Phase I studies on ThermoDox in recurrent chest wall breast cancer were published in the International Journal of Hyperthermia.
The article, titled "Two phase 1 dose-escalation/pharmacokinetics studies of low temperature liposomal doxorubicin (LTLD) and mild local hyperthermia in heavily pretreated patients with local regionally recurrent breast cancer," appears in the August 2014 issue.
The article describes the combined results of the two similarly designed Phase I trials with one study conducted at Duke University and the second conducted at other major breast cancer centers in the U.S., in which eligible patients with unresectable chest wall recurrences had progressed on the chest wall after prior hormone therapy, chemotherapy, and radiotherapy.
Patients received up to six cycles of ThermoDox every 21-35 days, followed immediately by chest wall mild local hyperthermia for 1 hour at 40-42°C.
In the first trial, 18 subjects received ThermoDox at 20, 30, or 40 mg/m². In the second trial, 11 subjects received ThermoDox at 40 or 50 mg/m².
The results showed that the maximum tolerated dose was 50 mg/m². The rate of overall local response was 48 percent, with five patients achieving complete local responses and nine patients having partial local responses.
It was concluded that ThermoDox at 50 mg/m² and mild local hyperthermia was safe, and this combined therapy produces objective responses in heavily pretreated RCWBC patients.
These Phase I data are consistent with the impressive interim results from Celsion's ongoing open-label Phase II DIGNITY Study of ThermoDox in RCWBC.
The DIGNITY Study will enroll at least 20 patients at several U.S. clinical sites and is evaluating ThermoDox in combination with mild hyperthermia using a treatment design equivalent to that used in the Phase I programs.
Of the 13 patients enrolled and treated, 10 were eligible for evaluation of efficacy.
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