*** CELN PRESS RELEASE ***
Monday May 3, 10:41 am Eastern Time
Company Press Release
Celsion Completes Phase One Human Studies Of Its BPH Treatment
-- Applying to FDA to Begin Multi-site Phase II Clinicals of IDE-approved System --
COLUMBIA, Md.--(BW HealthWire)--May 3, 1999-- Celsion Corp. (OTC BB:CELN) today announced that the Montefiore Medical Center in Bronx, NY has completed the Phase I clinical study of the Company's benign prostatic hyperplasia (BPH) 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.
''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) 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 General Hospital, and Duke University.
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