COLUMBIA, MD -- (MARKET WIRE) -- 04/21/11 --
Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, today announced that the Japan Patent Office (JPO) has granted the Japanese counterpart of the "Needham" composition of matter patent, "Temperature-Sensitive Liposomal Formulation," which is issued in various regions around the world, including the U.S. and European Union. Celsion holds a license agreement with Duke University under which the Company received exclusive worldwide rights to the Needham Patent Family, covering products, such as Celsion's Phase III product candidate, ThermoDox®, which are developed using Duke's temperature sensitive liposome technology. Celsion sublicensed its rights within Japan to Yakult Honsha Co., Ltd, the Company's Japanese development partner for ThermoDox®. The new patent, Japan Patent No. 4691253, provides patent protection for 20 years from the international filing date, which was June 9, 1999. Celsion has an additional divisional patent in the Needham Patent Family pending in Japan and continues to pursue various avenues, including patent term extensions, to maximize the Company's intellectual property protection in Japan and other territories.
"This patent, along with the expertise of Yakult Honsha, a leading Japanese pharmaceutical company, provide the resources for making ThermoDox® a commercial success in Japan," said Michael H. Tardugno, Celsion's President and Chief Executive Officer. "We continue to pursue a deliberate and comprehensive global intellectual property strategy aimed at maximizing the value of our drug delivery platform."
About ThermoDox® and the Phase III HEAT Study
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 HEAT Study, ThermoDox® is administered intravenously in combination with 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.
For primary liver cancer, ThermoDox® is being evaluated in a 600 patient global Phase III study at 76 clinical sites under an FDA Special Protocol Assessment. The 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 (PFS) with a secondary confirmatory endpoint of overall survival. A pre-planned, unblinded interim efficacy analysis will be performed by the independent Data Monitoring Committee when enrollment in the HEAT Study is complete and 190 PFS events are realized in the study population. Additional information on the Company's ThermoDox® clinical studies 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. The incidence of primary liver cancer is approximately 20,000 cases per year in the United States, approximately 40,000 cases per year in Europe and is rapidly growing worldwide at approximately 700,000 cases per year, due to the high prevalence of Hepatitis B and C in developing countries. The standard first line treatment for liver cancer is surgical resection of the tumor; however 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. There are few non-surgical therapeutic treatment options available as
radiation therapy and chemotherapy are largely ineffective in the treatment of primary liver cancer.
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 drug delivery systems. 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, Mayo Clinic, the University of Pisa, 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.
Source: Celsion Corporation
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