Celsion Completes Phase One Human Studies Of Its BPH Treatment.COLUMBIA, Md.--(BW HealthWire)--May 3, 1999-- -- Applying to 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 Begin Multi-site Phase II Clinicals of IDE-approved System -- Celsion Corp. (OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). BB:CELN) today announced that the 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]. in Bronx, NY has completed the Phase I clinical study of the Company's 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 BPH abbr. benign prostatic hyperplasia BPH Benign prostatic hypertrophy, a very common noncancerous cause of prostatic enlargement in older men. ) treatment system. Celsion's BPH system offers a non-surgical means of treating BPH. It utilizes a proprietary microwave balloon catheter with compression to open the prostatic urethra by creating a biological stent. The system is designed to provide immediate relief of urinary obstruction. "Based on the preliminary Phase I clinical results, I believe Celsion's system, when fully approved, can offer a significant advance for the treatment of BPH and that the Company should immediately proceed with Phase II evaluations," said Dr. Arnold Melman, principal investigator of the Phase I studies at the Montefiore Medical Center. He is also professor and chairman of the urology departments at both Montefiore and the Albert Einstein College of Medicine
The Albert Einstein College of Medicine (AECOM) is a graduate school of Yeshiva University. It is a private medical school located in the Jack and Pearl Resnick Campus of Yeshiva University in the Morris Park . "Our studies to date suggest that Celsion's treatment can be performed on an outpatient basis and the preliminary results suggest that the system, when fully tested and approved, could provide immediate symptomatic relief," added Dr. Melman. "If Phase II studies are successful, I believe Celsion's system should encourage a greater number of men with BPH to seek treatment, particularly those who suffer from milder forms of the condition." A February 1997 Piper Jaffray research report on urology estimated the overall costs of BPH therapy in the U.S. at $2.5-3.0 billion annually. In addition, only 23% of an estimated 7.5 million men suffering from BPH are under a doctor's care in the U.S. A December 1996 Dain Bosworth industry report estimated $8-10 billion is spent worldwide in treating BPH, which affects 50 percent of men over age 50. Celsion plans to apply for FDA approval for multi-site Phase II clinical studies, which are required in order to demonstrate safety and efficacy. Celsion intends to begin such studies this summer, assuming FDA approval for Phase II is granted by then. Once the Phase II studies are successfully conducted, the Company intends to commercialize its BPH system internationally and apply for FDA Premarket 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 ) to market the treatment in the U.S. Celsion Corporation is a research and development company dedicated to commercializing medical treatment systems for cancer and BPH using focused heat delivered by patented microwave technology. In addition to the BPH study performed at Montefiore Medical Center, clinical trials and further development of the Company's cancer treatment systems are being conducted by institutions such as the 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, , Massachusetts General Hospital Massachusetts General Hospital Health care The major teaching hospital for Harvard Medical School, widely regarded as one of the best health care centers in the world , and Duke University. 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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