Celsion Corporation, announced positive interim data from its ongoing open-label phase 2 DIGNITY Trial of ThermoDox in Recurrent Chest Wall Breast Cancer (RCWBC). The trial is designed to enroll 20 patients at several US clinical sites and is evaluating ThermoDox in combination with mild hyperthermia. Of the 13 patients enrolled and treated, 10 were eligible for evaluation of efficacy. Based on data available to date, 60 per cent of patients experienced a stabilisation of their highly refractory disease with a local response rate of 50 per cent observed in the 10 evaluable patients, notably 3 complete responses (CR), 2 partial responses (PR) and 1 patient with stable disease (SD).
These data are consistent with the previously reported positive Phase 1 data in RCWBC. Celsion previously reported combined clinical data from two Phase I trials, the company's phase 1 DIGNITY Study and the Duke University sponsored phase I trial of ThermoDox plus hyperthermia in RCWBC in December 2013. The two similarly designed Phase I studies enrolled patients with highly resistant tumours found on the chest wall and who had progressed on previous therapy including chemotherapy, radiation therapy and hormone therapy. There were 29 patients treated in the two trials (11 patients in the company's DIGNITY 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 per cent was reported in 14 of the 23 evaluable patients with 5 complete responses and 9 partial responses.
"These clinical results are very encouraging, given the fact that these patients have failed numerous previous treatments and have limited or no treatment options for this aggressive form of breast cancer. A chest wall recurrence of breast cancer has a poor prognosis with a significant impact on the patients' quality of life," said Imran Zoberi, M.D. at Washington University in St. Louis, Mo, a principal investigator for the DIGNITY trial. "I am pleased to be part of this important study and look forward to continuing my involvement in the DIGNITY Study and the future application of ThermoDox in this underserved patient population."
"In this population, tumour response is a clinically meaningful endpoint," noted Dr. Nicholas Borys, Celsion's senior vice president and chief medical officer. "Unchecked, progression of recurrent chest wall lesions results in severe and debilitating complications. ThermoDox's potential to stabilise, and in many cases affect remission, may provide an opportunity to improve quality of life; an option important for patients and physicians in their battle with this difficult form of malignancy."