DIGNITY study data on ThermoDox in BCRCW presented at European congress
Celsion has presented Phase I results from its Phase I/II DIGNITY study of ThermoDox in breast cancer recurrences at the chest wall at the ESMO 2012 congress, the annual conference for the European Society of Medical Oncology held in Vienna, Austria. The presentation, entitled "Breast Cancer Recurrences at the Chest Wall (BCRCW) When Standard Treatments (Tx) Have Failed: Lyso-thermosensitive liposomal doxorubicin (LTLD) + Mild Local Hyperthermia (MLH)", was delivered by Professor Hope S Rugo, from the University of California San Francisco School of Medicine, and provided a clinical update of the trial studying ThermoDox for breast cancer.
Drug-related adverse events were consistent with the known safety profile of doxorubicin including myelosuppression, alopecia, fatigue and nausea. Reversible myelosuppression was the most frequently observed effect, effectively managed with ASCO g-CSF treatment recommendations. Clinically meaningful responses were observed, including a target lesion response rate of 45 per cent without local progression (complete response 9.1 per cent, n=1/11, partial response 36.4 per cent, n=4/11). The study found that 50mg/m2 is the acceptable Phase II dose, as determined by independent review. Based on these results, Celsion is continuing into a Phase II study, to include additional clinical research sites.