Celsion Completes Expanded Phase I Trials For BPH; Montefiore Hospital to Lead Phase II, With Participation of Johns Hopkins and Walter Reed.Business/Technology Editors COLUMBIA, Md.--(BUSINESS WIRE)--April 11, 2000 Celsion Corporation (OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). BB:CELN) announced today that it has completed an expanded Phase I Human Clinical Trial testing the safety of a 45-minute outpatient procedure designed to offer rapid relief to patients suffering from BPH BPH abbr. benign prostatic hyperplasia BPH Benign prostatic hypertrophy, a very common noncancerous cause of prostatic enlargement in older men. - a prostate disease which impairs the ability to urinate of more than 50% of men over the age of 55. Utilizing patented focused microwave heat technology, the trial was conducted by Dr. Arnold Melman at New York's 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]. . Dr. Melman will monitor patient progress over the next 30 days and, at the conclusion, Celsion will report the results and apply for permission to proceed with a Phase II study. The Company also announced that Dr. Melman has agreed to lead the Phase II multi-center study that will be conducted at Montefiore, as well as at Johns Hopkins University Johns Hopkins University, mainly at Baltimore, Md. Johns Hopkins in 1867 had a group of his associates incorporated as the trustees of a university and a hospital, endowing each with $3.5 million. Daniel C. Hospital and at the Walter Reed Army Medical Research Institute. The purpose of a Phase II trial is to demonstrate treatment safety and efficacy. If successful, because Celsion's heat treatment system is a medical device rather than a pharmaceutical, the company can proceed immediately upon its conclusion to seek Pre-Market Approval (PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy ) from 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. for commercialization in the United States. BPH is a disease that primarily affects men over 55 in which the prostate expands constricting the urethra, and thereby restricting the normal passage of urine. The Company believes that, because of the inadequacy and inconvenience of currently approved methods, only a small percentage of men who currently suffer from BPH actually seek treatment. By developing an inexpensive outpatient treatment system that offers rapid relief, and does not require post-treatment catheterization catheterization Threading of a flexible tube (catheter) through a channel in the body to inject drugs or a contrast medium, measure and record flow and pressures, inspect structures, take samples, diagnose disorders, or clear blockages. , Celsion believes it can capture a significant share of a very large potential market. Celsion completed initial Phase I human trails at Montefiore in May, 1999. The resu1ts were so successful that the Company decided it could shorten the treatment time and make other changes that would present a more attractive procedure for patients while still producing excellent results. To test this revised protocol, an expanded Phase I trial, which has just been completed, involving 10 additional patients commenced in December, 1999. The Celsion procedure utilizes a specially designed catheter, which incorporates a dilation balloon that simultaneously delivers precision microwave heating, and compression to the urethral wall. The combination of heat and pressure is designed to give rapid relief to patients. About Celsion Based in Columbia, Maryland, Celsion Corporation is a research and development company dedicated to commercia1izing medical treatment systems for BPH, Breast Cancer and other diseases using focused heat delivered by patented microwave technology. Clinicals and further development of the company's treatment systems are being conducted by leading institutions such as Duke University, 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. , MIT MIT - Massachusetts Institute of Technology and Montefiore Medical Center. 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, possible changes in cost of materials, expense items, capital expenditures, capital structure, and other financial items; introduction of new products and possible acquisitions of 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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