Celsion and the American Liver Foundation Partner to Promote Awareness of Primary Liver Cancer and the ThermoDox® Phase III Global HEAT Study to Patients and Physicians
COLUMBIA, Md. & NEW YORK-(Business Wire)-September 14, 2009 - Celsion Corporation (NASDAQ:CLSN) and the American Liver Foundation (ALF) announced today that they have formed a partnership to provide education to physicians and liver patients about the treatment options for hepatocellular carcinoma (commonly referred to as primary liver cancer) and Celsion’s on-going ThermoDox Phase III global HEAT clinical study.
The partnership is comprised of multiple programs that roll out over several months to increase patient and physician awareness. Collaboratively, the two organizations have developed a webinar geared toward physicians that covers recent advances in the treatment of hepatocellular carcinoma and features the ThermoDox® HEAT clinical study. The alliance also includes outreach programs to increase awareness through regional ALF Divisions and patient support groups. On September 26, 2009, Celsion is sponsoring ALF’s Liver Life Walk in Los Angeles which reaches an audience of 50,000 people. Celsion and ALF have also developed an integrated media strategy that reaches internet communities, radio audiences, Health fair attendees, and physician networks. Information about the ThermoDox® clinical trial is posted on ALF’s national website at: www.liverfoundation.org/education/info/livercancer
“We are very pleased to have formed a partnership with the American Liver Foundation who has been the voice for the 30 million Americans with liver disease and through the successful execution of its mission has made a measurable difference in the fight against liver disease,” stated Michael H. Tardugno, President and Chief Executive Officer.
“We are enthusiastic to partner with Celsion to provide information about the ThermoDox® clinical trial to our membership” stated Rick Smith, President and Chief Executive Officer of the ALF. “ThermoDox® potentially provides an important new treatment option for primary liver cancer, an aggressive and difficult to treat cancer with a low five year survival rate”.
Celsion is conducting a 600 patient ThermoDox® global Phase III HEAT clinical study at up to sixty clinical sites under a Special Protocol Assessment with the U.S. Food and Drug Administration. The HEAT study is designed to evaluate the efficacy of ThermoDox® in combination with radio frequency ablation (RFA) when compared to patients who receive RFA alone as the control. The primary endpoint for the study is progression-free survival. Celsion has received Orphan Drug designation in the United States for ThermoDox® to treat primary liver cancer. Additional information on ThermoDox® clinical studies can be found at: www.clinicaltrials.gov
About the American Liver Foundation
The American Liver Foundation is the nation’s largest non-profit organization promoting liver health and disease prevention. The ALF achieves it‘s mission in the fight against liver disease by providing financial support for medical research, education for medical professionals, and advocacy and information for patients and their families, and by creating public awareness campaigns about liver wellness and disease prevention. Additional information on the ALF may be found at www.liverfoundation.org
About Primary Liver Cancer
Primary liver cancer is one of the most deadly forms of cancer and ranks as the fifth most common solid tumor cancer. The incidence of primary liver cancer is approximately 20,000 cases per year in the United States and is rapidly growing worldwide at approximately 1,000,000 cases per year, due to the high prevalence of Hepatitis B and C in developing countries. Among the standard treatment options for liver cancer is surgical resection of the tumor; however 80% to 90% of patients are ineligible for surgery. Radio frequency ablation (RFA) has increasingly become the standard of care for non-resectable liver tumors, but the treatment becomes less effective for larger tumors.
About ThermoDox®
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. ThermoDox® is administered intravenously and in combination with hyperthermia has the potential to provide local tumor control and improve quality of life. Localized mild hyperthermia (39.5-42 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® 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.
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