Celsion Corporation Announces Combined Clinical Data from Two Phase I Trials at the 2013 San Antonio Breast Cancer Conference Combined Safety and Efficacy Results with ThermoDox® plus Hyperthermia for Recurrent Breast Cancer at the Chest Wall
LAWRENCEVILLE, N.J., Dec.13, 2013 /PRNewswire/ -- Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, today announced the presentation of the combined clinical study results from the Company's Phase I DIGNITY study and the Duke University sponsored Phase I trial of ThermoDox® plus hyperthermia in Breast Cancer Recurrences at the Chest Wall (BCRCW) at the 2013 San Antonio Breast Cancer Conference during Poster Session #4 on Friday, December 13, 2013 between 7:30 am to 9:00 am (local time). The poster, titled "Novel Targeted Therapy for Breast Cancer Chest Wall Recurrence: Low Temperature Liposomal Doxorubicin and Mild Local Hyperthermia " was presented by Professor Hope S. Rugo, MD, from the University of California, San Francisco Comprehensive Cancer Center. A copy of the poster presentation is available on the Company's website at www.celsion.com.
The two similarly designed Phase I studies enrolled patients with highly resistant tumors found on the chest wall and who had progressed on previous therapy including chemotherapy, radiation therapy and hormone therapy. Unresectable BCRCW is very difficult to treat and often responds poorly to radiation and systemic chemotherapy. These patients can suffer from disfiguring tumors and clinical symptoms including pain, reduced range of motion, and skin ulceration with bleeding and potential necrotic, infected wounds. ThermoDox® in combination with mild hyperthermia was evaluated in these patients in up to six cycles. Both studies employed an open label 3+3 dose escalation study design to determine the Maximum Tolerated Dose (MTD), evaluate safety and determine early effects of ThermoDox® in combination with mild hyperthermia. 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% was reported in 14 of the 23 evaluable patients with 5 complete responses and 9 partial responses. Based on the results from these two Phase I studies, Celsion is currently enrolling up to 20 patients in an open label Phase 2 study at 5 US clinical sites.
"The patients enrolled in both of these Phase I trials are faced with limited or no treatment options. ThermoDox® and mild hyperthermia therapy appears to be active in these heavily pre-treated patients with recurrent breast cancer. Some patients even had prior exposure to doxorubicin or other anthracyclines," said Dr. Hope S. Rugo. "The impressive local response rate seen in these two studies was determined by lesion measurements and digital imaging data. Patients are pleased with the local control in the treated areas. I look forward to continuing my involvement in the Phase 2 portion of the DIGNITY study and its future application to clinical development of ThermoDox® across different cancers."
About Celsion Corporation
Celsion is an oncology drug development company dedicated to the development and commercialization of innovative cancer drugs including tumor-targeting treatments using focused heat energy in combination with heat-activated liposomal drug technology. Celsion has research, license, or commercialization agreements with leading institutions including the National Institutes of Health, Duke University Medical Center, University of Hong Kong, the University of Pisa, the UCLA Department of Medicine, the Kyungpook National University Hospital, the Beijing Cancer Hospital and the University of Oxford.
For more information on Celsion, visit our website: http://www.celsion.com.
Celsion wishes to inform readers that forward-looking statements in this release are made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, unforeseen changes in the course of research and development activities and in clinical trials by others; possible acquisitions of other technologies, assets or businesses; possible actions by customers, suppliers, competitors, regulatory authorities; and other risks detailed from time to time in the Company's periodic reports filed with the Securities and Exchange Commission.
Jeffrey W. Church
Senior Vice President and
Chief Financial Officer
SOURCE Celsion Corporation