Celsion Corporation (Nasdaq: CLSN) announced today that interim data from its Phase I/II DIGNITY trial of ThermoDox® in Recurrent Chest Wall (RCW) Breast Cancer were presented at the poster session at the 2010 Breast Cancer Symposium. The abstract provided updated clinical results from the 40 mg/m2 dose cohort. Additionally the company announced that the 50 mg/m2 dose cohort has now completed enrollment. This DIGNITY study evaluates ThermoDox in combination with microwave hyperthermia in women with RCW Breast Cancer. The poster session was held October 1, 2010 at the Gaylord National Hotel in Suburban Washington, DC.
The abstract, titled "Phase I/II study evaluating the maximum tolerated dose, pharmacokinetics, safety, and efficacy of hyperthermia and lyso-thermosensitive liposomal doxorubicin in patients with breast cancer recurrence at the chest wall," is authored by Brigid O'Connor, M.D., Ph.D., lead clinical investigator from the Rhode Island Hospital in Providence, RI.
Dr. Nicholas Borys, Chief Medical Officer at Celsion Corporation commented, "We continue to see clinical activity in our patients, with a satisfactory safety profile. Patients at the 40 mg/m2 dose demonstrated encouraging results. Recently, the DIGNITY Drug Safety Monitoring Board (DSMB) allowed for dose escalation to the 50 mg/m2 cohort. We are awaiting the DSMB to reconvene after this higher dose cohort completes follow-up in the fourth quarter of 2010. Upon DSMB review, we will develop plans on how best to proceed with the study."
"This positive clinical data along with increased enrollment provides momentum to our RCW trial," said Michael H. Tardugno, Celsion's President and Chief Executive Officer. "Outreach to the ASCO community will help increase awareness that the DIGNITY Study can be an important option for this underserved patient population and increase participation."
Principal investigator Dr. O'Connor commented, "Although treatment using heat sensitive liposomal doxorubicin with microwave hyperthermia (heat) is investigational at this time, we are encouraged that this approach may provide a promising outcome for breast cancer patients with painful loco-regional recurrence on the chest wall. Rapid evaluation of ThermoDox is warranted as we search for ways to provide patients with better treatment options for this devastating disease."
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