Celsion Corporation Announces Combined Clinical Data from Two Phase I Trials to be Presented 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., Sept. 9, 2013 /PRNewswire/ — Celsion Corporation (NASDAQ: CLSN), a leading 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 to be held on December 10 to December 14, 2013. The poster, titled “Novel Targeted Therapy for Breast Cancer Chest Wall Recurrence: Low Temperature Liposomal Doxorubicin and Mild Local Hyperthermia ” will be presented by Professor Hope S. Rugo, MD, from the UCSF School of Medicine. A copy of the poster presentation will be made available on the Company’s website following Dr. Rugo’s presentation.
The two Phase I studies enrolled patients that had failed previous standard chemotherapy and radiation therapy and have recurrent breast cancer on their chest wall. There are no effective treatments available for these chest wall tumors. ThermoDox® in combination with mild hyperthermia was evaluated in these patients in up to six cycles. The studies were designed to determine the Maximum Tolerated Dose (MTD), evaluate safety and determine early effects of ThermoDox® in combination with hyperthermia. Clinically meaningful responses were reported in 14 of the 23 evaluable patients. Based on the results from these two Phase I studies, Celsion is currently enrolling up to 40 patients in an open label Phase 2 study. Enrollment is being conducted at 5 US sites. Further information can be found on the Company’s website and at www.clinicaltrials.gov.
“The patients enrolled in both of these Phase I trials have failed previous treatment regimens including chemotherapy and radiation therapy. The cancer has now appeared on their chest wall and the patients are faced with limited or no treatment options. Breast cancer recurrence at the chest wall is difficult to treat and is characterized by disfigurement, pain and restriction of movement,” said Dr. Nicholas Borys, Celsion’s Vice President and Chief Medical Officer. “The data from these two Phase I studies provides strong evidence of ThermoDox’s broad potential clinical value across different cancers, including the ability to provide a new tool against aggressive, superficial tumors. We look forward to rapidly recruiting patients for the Phase 2 portion of the DIGNITY Study.”
About Celsion Corporation
Celsion is a leading oncology 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