COLUMBIA, Md., April 12 Celsion Corporation (Nasdaq: CLSN) today announced that Dr. Ronnie T.P. Poon from the University of Hong Kong and lead principal investigator for the Asia Pacific region of the Phase I ThermoDox® dose escalation trial will hold a press conference on Thursday, April 15, 2010 at 10:30 AM HKT (Wednesday, April 14, 2010 10:30 PM ET) to discuss the long-term follow-up of patients treated from April 2006 to December 2006. The majority of the cancer patients Dr. Poon enrolled were diagnosed with hepatocellular carcinoma (HCC), the same indication currently being evaluated in the global Phase III HEAT Study of ThermoDox® with RFA, for which Dr. Poon also serves as the lead investigator for the Asia Pacific region.
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"We first began studying ThermoDox in combination with RFA for liver cancer in a multi-center 24-patient Phase I safety study, with seven patients treated at our institution here in Hong Kong," said Dr. Ronnie T.P. Poon. "Not only did we witness safety and a dose response relationship, but more importantly, at least one of these patients who received the higher dose of ThermoDox continues to be tumor-free three years after treatment, which is remarkable for HCC patients. This initial experience has led me to remain committed to overseeing the Phase III global HCC study, and we expect to complete enrollment this year."
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"Dr. Poon's leadership and contribution to evaluating HCC patients in our Phase I study was instrumental to our pursuit of the Phase III HEAT study," said Michael H. Tardugno, President & Chief Executive Officer of Celsion Corporation. "The remarkable proof of clinical activity seen here leads us to believe ThermoDox has the potential to improve the lives of hundred of thousands of patients suffering from HCC in Asia and throughout the world if ThermoDox is approved."
About ThermoDox®
ThermoDox in combination with hyperthermia or ablation has the potential to provide local tumor control, extending and improving the 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 and liver 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 already demonstrated remarkable evidence of clinical activity in Phase I studies for primary liver cancer and recurrent chest wall breast cancer. For the primary liver cancer indication, Celsion has been granted FDA Orphan Drug designation. 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 ThermoDox Global Phase III HEAT 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, currently being conducted in 73 clinical trial sites in 11 countries, 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 one of the most deadly forms of cancer and ranks as the fifth most common solid tumor cancer, with Hepatocellular Carcinoma (HCC) as the most commonly known form of HCC. The incidence of primary liver cancer is approximately 20,000 cases per year in the United States and is rapidly growing worldwide at approximately over 660,000 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 70% to 80% 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 Celsion Corporation
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(R) to Yakult-Honsha for the Japanese market and has a partnership agreement with Philips Healthcare 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 world-wide such as the National Institutes of Health, Duke University Medical Center, the University of Hong Kong, and the Cleveland Clinic. 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.
Investor Contact Marcy Nanus The Trout Group 646-378-2927 [email protected]
SOURCE Celsion Corporation
