Celsion Treats First Patient in Phase I Clinical Trial of ThermoDox with Heat for Liver Cancer.COLUMBIA, Md. -- Celsion Corporation (AMEX AMEX See: American Stock Exchange :CLN) today announced that it has treated the first patient in its Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I to investigate the use of ThermoDox(TM) in combination with Radio Frequency Ablation (RFA RFA right frontoanterior (position of the fetus). Radiofrequency ablation (RFA) A procedure in which radiofrequency waves are used to destroy blood vessels and tissues. Mentioned in: Prenatal Surgery ) for liver cancer. ThermoDox, Celsion's temperature-sensitive liposomal encapsulation of doxorubicin, a common cancer drug, allows focused, concentrated delivery of the drug to the tumor target. The Phase I trial, which is being conducted at the National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland, is designed to determine the safe maximum tolerated dose and pharmacokinetic profile of systemically delivered ThermoDox administered in combination with RFA in the treatment of liver lesions. The investigational combination technology is designed to utilize an FDA-approved RFA device to ablate (destroy) the center of the tumor and to thermally activate the ThermoDox liposome to release its encapsulated doxorubicin to kill remaining viable cancer cells throughout the heated area, including the tumor margins. Dr. Augustine Cheung, Celsion's President and Chief Executive Officer said, "We are very excited to have treated this patient. This is the first step in Celsion's clinical plan to develop and commercialize ThermoDox as a heat-activated cancer drug for liver cancer treatment. We believe that the mechanism of action of RFA in conjunction with ThermoDox could result in the ablation of the tumor as well as viable cancer cells in the tumor margins. Effective destruction of cancer cells in the tumor margins may lead to a significant reduction in local tumor recurrence, which is the major limitation of RFA alone in treating liver cancer." Dr. Cheung continued, "We believe that liver cancer presents a significant opportunity for Celsion. Although the incidence of primary liver cancer in the U.S. is relatively low, presently, approximately 11,000 cases per year, the global incidence is estimated to be as much as 500,000 cases annually, with nearly an equivalent number of deaths. These worldwide cases are concentrated in Asia, particularly in China." ABOUT CELSION: Celsion Corporation, based in Columbia, Maryland, is a biotechnology company dedicated to the development and commercialization of treatment systems for cancer and other diseases using focused-heat energy in combination with other therapeutic devices, heat-activated genes and heat-activated drugs. Celsion has research, license or commercialization agreements with leading institutions such as the National Institutes of Health, Duke University Medical Center, Massachusetts Institute of Technology Massachusetts Institute of Technology, at Cambridge; coeducational; chartered 1861, opened 1865 in Boston, moved 1916. It has long been recognized as an outstanding technological institute and its Sloan School of Management has notable programs in business, , Harbor UCLA Medical Center UCLA Medical Center is a hospital located on the campus of the University of California, Los Angeles in Los Angeles, California. It is rated as one of the top three hospitals in the United States and is the top hospital on the West Coast according to US News & World Report. , Montefiore Medical Center Montefiore Medical Center, in the Bronx, New York, is the university hospital of the Albert Einstein College of Medicine. The hospital, named after Moses Montefiore, is one of the 50 largest employers in New York State [1]. and Memorial Sloan-Kettering Cancer Center The Memorial Sloan-Kettering Cancer Center (MSKCC) in New York City is a cancer treatment and research institution founded in 1884 as the New York Cancer Hospital. The main campus is located at 1275 York Avenue, between 67th and 68th Streets, with other locations in New in New York City New York City: see New York, city. New York City City (pop., 2000: 8,008,278), southeastern New York, at the mouth of the Hudson River. The largest city in the U.S. , Roswell Park Cancer Institute The Roswell Park Cancer Institute is a cancer research and treatment center located in Buffalo, New York. Founded in 1898 by Dr. Roswell Park, it was the first dedicated medical facility for cancer treatment and research in the United States. in Buffalo, New York, and Duke University. 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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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