$CLSN Announces DSMB Recommends Advancing DIGNITY Study of ThermoDox(R) Into Phase II

06/08/11 – Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, today announced that after reviewing safety data from the Company’s recently completed Phase I portion of the DIGNITY Phase I/II study of ThermoDox® and hyperthermia in recurrent chest wall (RCW# breast cancer #the DIGNITY Study#, an independent Drug Safety Monitoring Board #DSMB# has recommended advancing from Phase I to Phase II at 50 mg/m2 of ThermoDox®.

The DIGNITY Study is a multicenter, single-arm, open-label, potentially registrational trial enrolling up to 109 patients with RCW breast cancer. The study is designed to evaluate the potential for ThermoDox® in combination with hyperthermia to provide local control of superficial breast cancer recurrence. The primary endpoint is durable complete local response. The DIGNITY Study builds upon promising data from a Phase I dose escalation study conducted at the Duke University Medical Center, in which patients #n=16) demonstrated evidence of clinical activity, either stable disease, partial response or complete response. Toxicities are consistent with doxorubicin, the active agent in ThermoDox® and a widely used chemotherapeutic with a well established safety profile

via Celsion Announces Drug Safety Monitoring Board Recommends Advancing DIGNITY Study of ThermoDox(R) in Recurrent Chest Wall Breast Cancer Into Phase II | SYS-CON MEDIA.