Celsion Receives FDA Approval to Expand Phase I Human Studies of 'Microwave Urethroplasty' for BPH Treatment
Updated 10:04 AM ET September 10, 1999-- Revised Protocol Designed to Shorten Treatment Time and Reduce Software and Hardware Requirements for Treatment Delivery--
CELN 0.970 -0.030 (3.00%) COLUMBIA, Md. (BW HealthWire) - Celsion Corp. (OTC BB:CELN), a medical device and technology developer, today announced that it has received FDA approval for use of the Company's most recent benign prostatic hyperplasia (BPH) treatment protocol in an expanded Phase I BPH study of 20 patients based upon the results of the initial 10 patients treated. The revised protocol is designed to shorten the treatment time as well as simplify the software and hardware requirements for treatment delivery. Celsion believes these changes will enhance treatment efficacy and patient acceptability.
Celsion's BPH system utilizes a proprietary microwave balloon catheter to open the prostatic urethra via creation of a biological stent resulting from the simultaneous application of heat and pressure caused by balloon expansion. This procedure, termed "Microwave Urethroplasty," is designed to provide immediate relief of urinary obstruction.
"Based on the initial and follow-up data from the Phase I clinical results, I believe the product, when fully approved by the FDA, can offer a significant advance to provide immediate symptomatic relief to problems associated with BPH," 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. In addition, Dr. Melman added "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, since the treatment can be performed on an outpatient basis.
"It is anticipated that the expanded Phase I study will be followed by a multi-site Phase II clinical study. In addition to Montefiore Medical Center, the Company has received letters of intent from both Walter Reed Army Medical Center in Washington, DC and Johns Hopkins Bayview Medical Center, Baltimore, MD to participate in the Phase II study.
Celsion Corporation is a research and development company dedicated to commercializing medical treatment systems for cancer and benign prostatic hyperplasia 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 the Columbia Hospital (a Columbia/HCA Healthcare member), Duke University, Harbor UCLA Medical Center, 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 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.
Contact: Celsion Corporation John Mon, (410) 290-5390 www.celsion.com or OTC Financial Network Geoffrey Eiten, (888) 399-7541 ext. 13 www.otcfn.com/celn |
