Celsion Receives FDA Clearance to Initiate Clinical Trials for Treatment of Prostate Cancer With Heat-Activated Drug Therapy.Business Editors/Health & Medical Writers CELSION CORPORATION (AMEX AMEX See: American Stock Exchange :CLN CLN Clean CLN Community Learning Network CLN Colon CLN Celsion Corporation CLN Class Library for Numbers CLN Credit Linked Note CLN Comitato di Liberazione Nazionale (Committee of National Liberation) CLN Corn Lethal Necrosis ) today announced receipt of approval from 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. ) to proceed with human clinical trials for its investigational therapy for the treatment of prostate cancer. This therapeutic approach combines Celsion's focused-heat thermotherapy delivery system with a heat-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. that is designed, when activated, to deliver a chemotherapeutic agent to the targeted tumor site. Celsion filed its original Investigational New Drug application (IND) for these trials with the FDA on March 29, 2002. According to Dr. David Needham, Professor, Department of Mechanical Engineering and Material Science at Duke University and the inventor of this temperature-sensitive liposome, "The FDA approval of the Celsion IND is a true milestone event. Preclinical trials have shown impressive efficacy for the new formulation plus focused heat, we are now at a point where we can test our specially designed liposome in humans and determine if the improved chemotherapeutic efficacy translates to human disease." With the clearance of the IND by the FDA, Celsion will undertake Phase I clinical trials at 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, NY, one of the leading cancer centers in the United States. According to Dr. Donald ("Skip") Trump, a national cancer leader in innovative clinical trials in prostate cancer and Senior Vice President for Clinical Research at Roswell Park, "The go-ahead from the FDA is the green light we have been waiting for in order to initiate human studies using heat-activated liposomes Liposomes Aqueous compartments enclosed by lipid bilayer membranes; liposomes are also known as lipid vesicles. Phospholipid molecules consist of an elongated nonpolar (hydrophobic) structure with a polar (hydrophilic) structure at one end. for the targeted delivery of high dose chemotherapy. We are excited to be collaborating with Celsion on the first of what we hope will be many trials in this promising area of drug delivery." According to Dr. Augustine Cheung, Celsion's founder and Chief Executive Officer, "I view the approval by the FDA to go ahead with our human trials in targeted drug delivery Scientists began to study targeted drug delivery, because the traditional drug delivery system had many disadvantages, such as high toxic effect and high minimum effective dose. In traditional drug delivery system, after the patient takes some drugs, the drugs will be all over his body that combines focused-heat therapy with temperature-sensitive liposomes as a validating event for Celsion. This study, along with our ongoing studies using focused-heat for breast cancer, demonstrates Celsion's commitment to developing more effective and less toxic treatments for cancer patients." Celsion has the exclusive worldwide commercial licenses to the Duke heat-activated liposome technology. 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 technology delivered by patented microwave technology. 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. , the Center for Breast Surgery at Columbia Hospital in Florida, 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]. , Memorial Sloan Kettering Cancer Center in New York, Roswell Park Cancer Institute in Buffalo, New York, and Duke University. For more information on Celsion, visit our website: http//www.celsion.com. 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. Investors 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; possible changes in cost and timing of development and testing, capital structure, and other financial items; changes in approaches to medical treatment; introduction of new products 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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