COLUMBIA, Md., April 20 Celsion Corporation (Nasdaq: CLSN) today announced that Dr. Thanjavur S. Ravikumar, from the Geisinger Health System and a principal investigator of the Phase I ThermoDox® dose escalation trial, gave an oral presentation at the Liver Tumors Panel session of the 9th World Congress of the International Hepato-Pancreato-Biliary Association (IHPBA) in Buenos Aires, Argentina. The presentation, titled "A Phase I Trial of ThermoDox® in Patients Undergoing Radiofrequency Ablation (RFA) of Liver Tumors," provided a summary of the data as well as illustrative patient case studies. The trial results not only support the use of ThermoDox® plus RFA for the treatment of primary liver cancer, but also provide supportive evidence for Celsion to evaluate the effects of ThermoDox in patients with colorectal liver metastases (CRLM).
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"Eight out of the twelve patients we treated in this study had CRLM, some of whom had as many as nine lesions with multi-focal disease," said Dr. Ravikumar. "ThermoDox is a unique therapy that is showing great promise in treating this very aggressive disease. I look forward to providing long-term follow-up and a publication at a future date."
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"CRLM is a major problem in the western hemisphere, just as primary liver cancer is in Asia Pacific," remarked Michael H. Tardugno, President & Chief Executive Officer of Celsion Corporation. "We look forward to bringing ThermoDox to the market in the US, which will help address an estimated 300,000 cases of liver metastases, almost half of which come from colorectal cancer."
Celsion previously announced its plans to conduct a randomized Phase II CRLM study to further evaluate the efficacy of ThermoDox plus RFA. This trial will be initiated later this year following the completion of enrollment in Celsion's pivotal Phase III HEAT trial for primary liver cancer trial. "Local control in patients with liver metastasis is of interest to the medical community," noted Nicholas Borys, Celsion's Vice President and Chief Medical Officer. "This study adds to the growing body of scientific data that ThermoDox may play an important role as an adjunct to liver tumor ablation."
Dr. Ravikumar's oral presentation is available on Celsion's website at www.celsion.com/events.cfm.
About Colorectal Liver Metastases (CRLM)
The American Cancer Society estimates that there were about 147,000 new cases of colorectal cancer and about 50,000 colorectal cancer deaths during 2009. Up to 25% of patients with colorectal cancer present with liver metastases and another 50% develop liver metastases within 5 years. Median survival of patients with colorectal liver metastases (CRLM) is 6-12 months if untreated. While hepatic resection is potentially curative, most CRLM patients are inoperable and therefore radiofrequency ablation (RFA) is the most frequently used local treatment modality for CRLM. Because RFA is both efficacious and widely accepted, a rational strategy is to attempt to increase its efficacy for medium (3.1-5.0 cm) and large (> 5.0 cm) CRLM tumors with an adjuvant such as ThermoDox.
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
