Columbia-based Celsion Corp. said yesterday that it had gotten government approval to begin testing on patients the safety and effectiveness of a 45-minute outpatient procedure designed to rapidly relieve symptoms of a benign prostate disease.
Johns Hopkins University Medical Center in Baltimore will be among the six sites at which Celsion will test its patented treatment system on 160 men.
The company has successfully completed Phase I safety trials of the system, designed to relieve the constricted urethra that makes urinating difficult for men with enlarged prostates.
The pivotal Phase II trials announced yesterday, if successful, will clear the way for Celsion to put the treatment on the market, Celsion general manager John Mon said.
Dr. Arnold Melman, the company's principal investigator and chair of the urology departments at Montefiore Medical Center and Albert Einstein College of Medicine in the Bronx, N.Y., said in a statement that he is "optimistic about the procedure based upon results already obtained from Phase I and Phase IA studies, which involved a total of 20 patients."
Benign Prostatic Hyperplasia, the disease Celsion's system is designed to treat, affects more than 50 percent of men older than 55 and 75 percent of all men older than 80, company filings with the Securities and Exchange Commission say.
At least $3 billion is spent on the disease annually in the United States and $9 billion worldwide, although Celsion says the market for its treatment may be larger because some men with symptoms do not seek treatment.
One possible reason: The current options for BPH are limited to painful surgery or lifelong drug therapy, which Celsion's filings claim are only 50 percent as effective as the surgery.
Celsion's system involves inserting its patented microwave balloon catheter into the urethra to enlarge it, then heating the affected area from the inside out to fix the urethra in a more open position and kill some of the diseased prostate cells surrounding it. The balloon catheter is similar to the balloon used in balloon angioplasty, a common treatment for opening constricted blood vessels.
The two other sites at which the company has announced that patients will be enrolled for the trials are Walter Reed Army Medical Center in Washington and Montefiore. The three other sites have yet to be announced.
Patients interested in enrolling may call Mon at Celsion for information at 410-290-5390.
Celsion also is testing a heat-focused microwave technology to shrink breast-cancer tumors. That treatment is in Phase I clinical trials in West Palm Beach, Fla. Shares of the company closed yesterday at $3.625, up 18.75 cents, or 5.45 percent, on the American Stock Exchange.