COLUMBIA, Md., Dec. 17 Celsion Corporation (Nasdaq: CLSN) announced today that Celsion, in partnership with the American Liver Foundation (ALF), launched a CME accredited educational webcast for physicians that features recent advances made in the treatment of hepatocellular carcinoma(HCC) and Celsion's ThermoDox® Phase III HEAT clinical study.
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The webcast is presented by Ronnie T. P. Poon, MD, an internationally recognized liver surgeon at Queen Mary Hospital, Professor of Surgery at the University of Hong Kong, and a Principal Investigator in the Asia Pacific region for the ThermoDox HEAT study. In the webcast, Dr. Poon notes that radiofrequency ablation (RFA) has become the standard of care for early stage, non-resectable HCC and can be curative for smaller tumors (<3cm). The webinar is being hosted by the ALF on its national website and can be viewed at http://www.liverfoundation.org/education/webcasts
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"Dr. Poon's webcast provides current information for physicians and patients, as it highlights the evolution and recent advances made in the treatment of HCC," stated Michael H. Tardugno, Celsion's President and Chief Executive Officer. "The webcast underscores the need for innovative, new therapies such as ThermoDox because despite recent improvements in treatment, five year HCC survival rates are still in the single digits. ThermoDox has demonstrated remarkable evidence of clinical utility in early stage clinical trials and holds great promise for HCC patients as there is currently no chemotherapeutic standard of care."
ThermoDox Global Phase III HCC Study
Celsion's global ThermoDox Phase III study for HCC, the most common form of primary liver cancer, is being conducted under a Special Protocol Assessment with the U.S. Food and Drug Administration (FDA). The 600 patient study, which is expected to have 60 clinical trial sites activated by the end of 2009, 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 is progression free survival with a secondary confirmatory endpoint of overall survival. A pre-planned, un-blinded interim efficacy analysis will be performed by an independent Data Management Committee when 50% of the progression free survival endpoint events are realized in the study population. Based on an historical review of RFA cases, Celsion expects the study could be completed by the middle of 2011, and pending positive data, a New Drug Application would be submitted to the FDA before the end of 2011. Additional information on the ThermoDox Phase III clinical study may be found at http://www.clinicaltrials.gov.
About Primary Liver Cancer
Primary liver cancer is a type of cancer that begins in the cells of the liver and is not typically detected early, often resulting in a poor patient prognosis. Mortality among primary liver cancer patients is one of the world's highest and ranks as the fifth most common solid tumor cancer. The incidence of primary liver cancer in the USA is approximately 20,000 cases per year and is rapidly growing worldwide. Globally there are approximately 660,000 cases per year, with the major risk factor being Hepatitis B and C in high prevalence in developing countries. There are few non-surgical therapeutic treatment options available as radiation and chemotherapy are largely ineffective in the treatment of primary liver cancer. The standard first line treatment for liver cancer is surgery, either resection or liver transplantation, but 70% to 80% of patients are ineligible for surgery. RFA with limitations, has shown to be effective and has increasingly become the standard of care for non-resectable liver disease. Celsion is evaluating its lead drug, ThermoDox, in combination with RFA to improve the range and efficacy of the RFA procedure to treat this difficult disease.
About ThermoDox
ThermoDox in combination with hyperthermia has the potential to provide local tumor control and improve quality of life. 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 including breast cancer. Localized mild hyperthermia (40-42 degrees Celsius) releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.
ThermoDox has demonstrated evidence of efficacy in a Phase I study for primary liver cancer and the FDA has granted Orphan Drug designation for this indication. For recurrent chest wall breast cancer, ThermoDox is being evaluated in a pivotal Phase I/II open-label, dose-escalating trial that is designed to measure durable local complete response at the tumor site.
ThermoDox® is a registered trademark of Celsion Corporation
About Celsion
Celsion is dedicated to the development and commercialization of innovative oncology drugs including tumor-targeting treatments using focused heat energy in combination with heat-activated drug delivery systems. Celsion has licensed ThermoDox® to Yakult-Honsha for the Japanese market and has a partnership agreement with Phillips Medical to jointly develop its heat activated liposomal technology in combination with high intensity focused ultrasound to treat difficult cancers. Celsion has research, license, or commercialization agreements with leading institutions such as the National Institutes of Health, Duke University Medical Center, University of Hong Kong, Cleveland Clinic, and the North Shore Long Island Jewish Health System.
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.
Contacts: Celsion Corporation Sean Moran, 410-290-5390 Senior Vice President and Chief Financial Officer [email protected] or The Trout Group Marcy Nanus, 646-378-2927 [email protected]
SOURCE Celsion Corporation
