Aug 6, 2012
Clinical update on DIGNITY trial to be presented at ESMO 2012
LAWRENCEVILLE, NJ, 1 August 2012 – Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, today announced the acceptance of an abstract and presentation at the ESMO 2012 Congress, the annual conference for the European Society of Medical Oncology held in Vienna, Austria from September 28 to October 2, 2012. The presentation, titled "Breast Cancer Recurrences at the Chest Wall (BCRCW) When Standard Treatments (Tx) Have Failed: Lyso-thermosensitive Liposomal Doxorubicin (LTLD) + Mild Local Hyperthermia (MLH)," will be delivered by Professor Hope S. Rugo, MD from the UCSF School of Medicine, and will provide a clinical update of the Phase I/II DIGNITY trial studying ThermoDox® for breast cancer.
"We are excited to provide an update from our multicenter DIGNITY trial of ThermoDox® in breast cancer, a study which has, to date, demonstrated remarkable clinical benefit in a very late-stage, underserved patient population," said Michael H. Tardugno, Celsion's President and Chief Executive Officer. "ThermoDox's® clinical utility in this highly treatment-resistant setting points to its potential within a variety of superficial tumors, and could provide medical oncologists with an important tool to combat these often aggressive tumors."
Professor Hope S. Rugo, MD commented, "The initial experience with hyperthermia and ThermoDox® has been very encouraging and provides initial safety and early efficacy data in several patients showing responses in this highly refractory and debilitating disease. These patients previously received over an average of four prior chemotherapy regimens along with prior radiation therapy. The continuation of the ThermoDox® trial will provide more efficacy data to potentially advance treatment for this patient population."
ThermoDox® is a proprietary heat-activated liposomal encapsulation of doxorubicin, an approved and frequently used oncology drug for the treatment of a wide range of cancers. In the Company's Phase III HEAT Study and Phase II ABLATE Study, ThermoDox® is administered intravenously in combination with Radio Frequency Ablation (RFA). Localized mild hyperthermia (39.5 - 42 degrees Celsius) created by the RFA releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.
The Company's Phase III HEAT Study, a randomized, double-blind, placebo-controlled clinical trial of ThermoDox® in combination with radiofrequency ablation (RFA) for the treatment of hepatocellular carcinoma (HCC), also known as primary liver cancer, is being conducted at 79 clinical sites under an FDA Special Protocol Assessment. The study is designed to evaluate the efficacy of ThermoDox® in combination with RFA when compared to patients who receive RFA alone as the control. The primary endpoint for the study is progression-free survival. The Company's Phase II ABLATE Study is being conducted at four clinical sites in the U.S. and is a randomized, blinded clinical trial of ThermoDox® in combination with RFA for the treatment of colorectal liver metastases with a PFS endpoint. Additional information on the Company's ThermoDox® clinical studies may be found at www.clinicaltrials.gov.
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.