biz.yahoo.com
Now we're talkin'... gotta love it.
Thursday March 28, 1:29 pm Eastern Time
Celsion: Urethroplasty Systems Effective In Phase 2 Study
COLUMBIA , Md. -(Dow Jones)- Celsion Corp. (CLN) said a Phase II trial showed that its Microwave Urethroplasty heat-treatment system was more effective in treating men with an enlarged prostate than a government-approved drug made by Merck & Co . (MRK).
In a press release Thursday, the research and development company said the three-month trial compared patients who received Celsion's Microwave Urethoplasty treatment system with patients treated with a daily 5-milligram dose of Merck's Proscar drug.
Proscar is developed by Merck and has been regularly prescribed to treat benign prostatic hyperplasia, or BPH, since gaining Food and Drug Administration approval in 1992. BPH, commonly referred to as enlarged prostate, is a noncancerous urological disease that affects many older men.
Celsion said the trial demonstrated that patients undergoing its treatment had achieved statistically significant greater reductions in their symptom scores at each of the three follow-up dates - the first two weeks, the first month and the first three months.
About 75% of the patients undergoing Microwave Urethroplasty experienced reductions in their symptom scores averaging in excess of 48% after two weeks, the company said. Celsion said this was a significantly faster improvement than for the patients treated with Proscar, who had not reached that result after three months.
More than 90% of the Microwave Urethroplasty patients experienced reductions averaging in excess of 50% after three months, Celsion said.
Daniel Reale, president of Celsion's BPH division, said in a statement that the results of the trial exceeded the company's expectations. "Patients experienced more rapid relief and fewer side effects," he said. "More importantly, the company's trial success was measured against a major drug therapy."
A Merck spokeswoman said she couldn't comment at this time because she was unaware of this study. |
