Celsion Corporation Funds ThermoDox(TM) Advanced Breast Cancer Study at Duke University.COLUMBIA, Md. -- Celsion Has Provided Duke University with a Research Grant to Support a Phase I Study for the Use of ThermoDox in Patients with Local-Regionally Recurrent Breast Cancer CELSION CORPORATION (AMEX AMEX See: American Stock Exchange :CLN) today announced that it had agreed to provide Duke University with a research grant and clinical supplies of ThermoDox, Celsion's proprietary doxorubicin-encapsulated thermo-sensitive liposome liposome (lī`pəsōm', lĭp`ə–), microscopic, fluid-filled pouch whose walls are made of layers of phospholipids identical to the phospholipids that make up cell membranes. , to support a Phase I, open-label study of the safety and pharmacokinetics in patients with local-regionally advanced breast cancer. The heat required to trigger doxorubicin release from the temperature sensitive liposome will be provided by a BSD (Berkeley Software Distribution) The software distribution facility of the Computer Systems Research Group (CSRG) of the University of California at Berkeley. 500 system. Duke University has previously reported promising results from a Phase I breast cancer study designed to demonstrate the ability of thermotherapy to enhance the therapeutic activity of non temperature sensitive liposomal encapsulations of doxorubicin plus traditional paclitaxel (Taxol(R)) in the management of locally advanced breast cancer. The lead investigator on both the reported Phase I study and a recently completed related Phase II study was Kimberly Blackwell, M.D. of Duke University Medical Center. Dr. Blackwell said, "Given the potential of ThermoDox to provide higher concentrations of doxorubicin in the immediate area of the tumor, I am interested in studying the ability of ThermoDox to further enhance the therapeutic action previously achieved by the use of heat in combination with liposomal doxorubicin. ThermoDox will offer an exciting potential treatment option to this patient group for whom the medical options are very limited." Local-regionally recurrent breast cancer is a condition that occurs in post mastectomy patients where lesions recur on the chest wall. There is currently no established standard of care for this condition. Dr. Lawrence Olanoff, Celsion's Chief Executive Officer, commented, "We are very pleased to be able to support this study as a way of continuing Celsion's past efforts to develop better treatments for breast cancer. Strategically this indication fits Celsion very well, in that the heating device required to trigger the release of doxorubicin from the ThermoDox formulation already exists. Together with our current Phase I study in liver cancer, this breast cancer study continues our transition from a medical device company to a biopharmaceutical concern focused on development of oncology products." 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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