Celsion Corp. Receives FDA Approval to Begin Clinical Trials for the Treatment of Benign Prostatic Hyperplasia; Human Trials to Commence at the Montefiore Medical Center.

COLUMBIA, Md.--(BW HealthWire)--June 1, 1998--Celsion Corporation (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) system.

The FDA approval of the Company's Investigational Device Exemption (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). The Company expects to obtain data demonstrating the system's safety and efficacy in order to apply for a Pre Market Approval (PMA) 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, frequent urination, weak urine flow, and in severe conditions the inability to urinate. 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 creates a natural biological stent in the urethra, thus providing immediate relief of urinary obstruction. 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

Unlike all other BPH treatments, Celsion's proprietary system offers a single, in the office procedure with immediate relief from obstruction and long term symptom control without pain or subsequent catheterization. The non-surgical urethroplasty procedure provides 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 assures long term treatment benefits without the side effects caused by other BPH treatments.

The Company estimates its pain-free system will encourage up to 50% of individuals who suffer from BPH to seek treatment; 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 (MGH), Montefiore Medical Center, and Duke University in the United States, and Hammersmith Hospital and Oxford University in England.

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