Celsion's Pre-Clinical Results on the Use of ThermoDox in the Treatment of Liver Cancer Presented at the 89th Annual Radiological Society of North America --RSNA--.Business Editors/Health/Medical Writers COLUMBIA, Md.--(BUSINESS WIRE)--Dec. 8, 2003 CELSION CORPORATION (AMEX AMEX See: American Stock Exchange :CLN) announced today that Bradford J. Wood, M.D. Senior Clinical Investigator, Diagnostic Radiology Department - Surgery Branch - National Cancer Institute National Institutes of Health (NIH "Not invented here." See digispeak. NIH - The United States National Institutes of Health. ) presented the results of Preclinical studies conducted in large animals by the 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. in collaboration with the NIH on the feasibility of using Celsion's novel drug compound, ThermoDox, in combination with Radiofrequency Ablation (RFA) in the treatment of liver cancer. ThermoDox is Celsion's, proprietary temperature sensitive liposomal formulation, which encapsulates doxorubicin, a common cancer drug. The contemplated treatment approach will utilize the ablation zone of RFA (80 degs C. or above) to ablate the center of the tumor and the associated extended low temperature zone (40 -42 degs C.) to activate and release the doxorubicin at the tumor margins. These results, which were selected for presentation at the meeting as a "New and Hot Topic", demonstrated that ThermoDox, used in this manner, deposited two to four times more doxorubicin than conventional drug delivery. The premise of these studies is that the combination of RFA with ThermoDox may reduce high local recurrence rates of liver tumors currently treated with RFA alone. It is believed that RFA, though effective in ablation of the tumor, is ineffective in addressing the presence of cancer cells in the margins. ThermoDox holds the promise of depositing high concentrations of doxorubicin in the margins with the goal of eliminating cancer cells, thus reducing local recurrences. The preclinical work corroborates this premise and is in line with other work done to support a Phase I dose escalation study, currently being conducted by Celsion, using ThermoDox for the treatment of Prostate Cancer. In the Prostate Cancer study, Celsion uses its Microfocus BPH 800 Microwave Urethroplasty(TM) system to generate the heating required to release the drug from ThermoDox. This system is currently under Pre-marketing Approval (PMA) review with the FDA for the treatment of Benign Prostatic Hyperplasia benign prostatic hyperplasia n. Abbr. BPH A nonmalignant enlargement of the prostate gland commonly occurring in men after the age of 50, and sometimes leading to compression of the urethra and obstruction of the flow of urine. (BPH). According to Dr. Augustine Cheung, Celsion's President and Chief Executive Officer, "This preclinical work on ThermoDox is part of Celsion's plan for the development of tumor-targeting cancer treatment products based on the platform of using focused heat energy and heat activation of temperature sensitive liposomal drug delivery systems. Celsion is planning to submit an IND to begin evaluating the safety and efficacy of using ThermoDox in conjunction with RFA for the treatment of liver cancer. Clearance by the FDA would be another important step toward Celsion's evolution as a major player in the area of heat activated drug therapy for the treatment of cancer. Expanding the use of ThermoDox for treatment of liver cancer, in addition to the ongoing human trial using ThermoDox for prostate cancer clearly establishes Celsion as a leader in this space." About Celsion: Celsion Corporation, based in Columbia, Maryland, is a research and development company dedicated to commercializing medical treatment systems for cancer and other diseases using focused-heat energy delivered by patented microwave technology. 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 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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