Celsion Files IND to Initiate Human Clinical Trials for the Use of ThermoDox in the Treatment of Liver Cancer.Business Editors/Health/Medical Writers COLUMBIA, Md.--(BUSINESS WIRE)--Jan. 8, 2004 CELSION CORPORATION (AMEX AMEX See: American Stock Exchange :CLN) today announced plans to undertake human clinical trials to treat liver cancer. On December 22, 2003, Celsion filed an Investigational New Drug application (IND) with the Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for the use of ThermoDox(TM), Celsion's proprietary temperature sensitive liposomal formulation, which encapsulates doxorubicin, a common cancer drug. The Phase I study will be conducted at the National Institutes of Health (NIH "Not invented here." See digispeak. NIH - The United States National Institutes of Health. ) Clinical Center in Bethesda, MD. The Phase I trial is designed to determine the maximum safely tolerated dose of ThermoDox when used in combination with Radiofrequency 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 ) in the treatment of liver cancer. The contemplated treatment approach will utilize the ablation zone of RFA (80 degrees C or above) to ablate the center of the tumor and the associated extended low temperature zone in the tumor margins to activate and release the doxorubicin in order to kill viable cancer cells in the tumor margins. Dr. Augustine Cheung, Celsion's President and Chief Executive Officer said, "We believe that the mechanism of action of RFA in conjunction with ThermoDox, using heat sensitive nanoparticles to target cytotoxic drugs could result in high concentrations of the drug in the tumor thus ablating the tumor as well as viable cancer cells in the tumor margin. This may lead to a significant reduction of local tumor recurrence, which is currently the major limitation of using RFA alone to treat liver cancer." The clinical plans for liver cancer rely, in part, on the pre-clinical results of the work, conducted in large animals by the FDA in conjunction with the NIH. This data was presented by Dr. Bradford J. Wood, Senior Clinical Investigator, Diagnostic Radiology Department, Imaging Sciences Program, NIH Clinical Center; Surgery Branch, National Cancer Institute, at the National Institutes of Health at the 89th Annual Radiological Society of North America The Radiological Society of North America (RSNA), founded in 1915, has the purpose to "promote and develop the highest standards of radiology and related sciences through education and research". (RSNA) in December 2003. These results demonstrated that ThermoDox used in this manner deposited two to four times more doxorubicin than conventional drug delivery. According to Daniel S. Reale, Executive Vice President and President of Celsion's Oncology Division, "The filing of this IND for the use of ThermoDox to address significant unmet medical needs, including primary liver cancer, recurrent liver cancer and metastases to the liver, marks an important milestone for Celsion. This trial increases our cancer treatment portfolio building upon our ongoing Phase I trial using ThermoDox to treat prostate cancer in conjunction with Celsion's proprietary microwave heating technology (the Microfocus BPH800 Microwave Urethroplasty(TM) System) and further establishes Celsion as a leader in the area of heat activated drug therapy for the treatment of cancer." National Institutes of Health Disclaimer Purchase of this equipment should not be viewed as an endorsement or implied endorsement by the National Institutes of Health, its Institutes or Centers or Clinical Center, of the Celsion Corporation, its products or services. 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, either administered alone, or in combination with other therapeutic devices, heat activated genes and heat activated drugs. In January 2003, Celsion entered into a strategic alliance with Boston Scientific Corporation (NYSE NYSE See: New York Stock Exchange :BSX) in which Boston Scientific will initially distribute Celsion's BPH product worldwide. Boston Scientific currently owns approximately 7% of Celsion's outstanding stock. Celsion has research, license or commercialization agreements with leading institutions such as the National Institute 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: 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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