Celsion Corp. Corrects and Replaces Previous Announcement.COLUMBIA, Md.--(BW HealthWire)--June 1, 1998-- Receives 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. Approval to Begin Clinical Trials 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. ; Human Trials to Commence at 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]. Celsion Corporation (OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). BB:CELN), formerly Cheung Laboratories, Inc., today announced that the U.S. Food and Drug Administration (FDA) approved the Company to commence phase one clinical trials of its patented benign prostatic hyperplasia (BPH BPH abbr. benign prostatic hyperplasia BPH Benign prostatic hypertrophy, a very common noncancerous cause of prostatic enlargement in older men. ) system. The FDA approval of the Company's Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and (IDE) application, which was filed in April 1998, allows Celsion to begin patient studies as scheduled at the Montefiore Medical Center in New York once cleared by the Institutional Review Board (IRB IRB See: Industrial Revenue Bond ). The Company expects to obtain data demonstrating the system's safety and efficacy in order to apply for a 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 ) for commercialization. "We're excited about starting the human trial of Celsion's BPH treatment system because of the positive results we have experienced in our preclinical animal studies," stated Dr. Arnold Melman, principal investigator of the clinical studies and professor and chairman of Urology at Albert Einstein College of Medicine/Montefiore Medical Center. In vivo preclinical evaluations, completed by Dr. Melman in February 1998, demonstrated the formation of a biological stent using large dogs with advanced BPH, indicated that biological stent creation using heat and compression is feasible, and concluded that Celsion's system is safe for patient use. The enlargement of the prostate gland due to aging causes the medical condition BPH. Resulting symptoms include pain in urination urination Process of excreting urine from the bladder (see urinary system). Nerve centres in the spinal cord, brain stem, and cerebral cortex control it through involuntary and voluntary muscles. The need to void is felt when the bladder holds 3. , frequent urination, weak urine flow, and in severe conditions the inability to urinate urinate /uri·nate/ (u´ri-nat) to discharge urine. u·ri·nate v. To excrete urine. urinate to void urine. . The Company's treatment system is designed to improve urinary flow rate and alleviate symptoms in patients who suffer from BPH; an estimated 50% of men over 55 or 7.2 million men in the United States. The Company's patented BPH system incorporates patented technologies into a non-surgical urethroplasty procedure which created in animal tests a natural biological stent in the urethra, and is expected to provide immediate relief of urinary obstruction in clinical trials. In addition, the unique microwave balloon catheter delivers transurethral microwave heating which shrinks the prostate and is anticipated to yield long term treatment benefits. "The FDA's approval allows us to begin actual clinicals quickly," said Spencer Volk, president and chief executive officer of Celsion. "We are confident that the clinicals will be as positive as our previous in vivo studies and will enable us to rapidly proceed to commercialization." Competitive Advantages & Market Potential Celsion's proprietary system will offer a single, in-the-office procedure which is designed to provide immediate relief from obstruction and is also designed to provide longer term symptom control without subsequent 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. . The Company believes other systems do not offer these advantages. The non-surgical urethroplasty procedure is expected to provide BPH patients immediate urine-flow relief by forming the biological stent, a feature absent from all other current commercial BPH thermotherapy systems. Since Celsion's system uses lower temperatures than other thermotherapy systems, it is expected to provide its treatment benefits without side effects. The Company believes its system will encourage more individuals who suffer from BPH to seek treatment since only 30% currently do so. This should notably expand the market for BPH treatments which is presently estimated at $3 billion in the U.S. and $9 billion worldwide. Celsion Corporation, formerly Cheung Laboratories, Inc., is a research and development company dedicated to commercializing medical treatment systems for cancer and benign prostatic hyperplasia (BPH) utilizing deep focused heat delivered by patented microwave technology. Celsion is presently working with leading institutions to develop its focused heat treatments, including 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 (MGH), Montefiore Medical Center, and Duke University in the United States, and Hammersmith Hospital and Oxford University in England. -0- 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. 10220-1 Old Columbia Road, Columbia MD 21046-1705 (410) 290-5390 FAX: (410) 290-5394
CONTACT: Celsion Corporation OTC Financial Network
John Mon Geoffrey Eiten
(410) 290-5390 (888) 399-7541 / (781) 444-6100
www.celsion.com www.otcfn.com/celn
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