icnmgrjill
04-12-2008, 06:47 AM
Urigen Pharmaceuticals, Inc. (OTCBB:URGP), http://www.urigen.com, today announced the early closure of the URG101-104 study due to positive, statistically significant interim analysis results in both the primary and all secondary endpoints. The top line results of the interim analysis which was planned at 50% enrollment were previously released March 12, 2008. "Based upon further review, it has been determined continuing enrollment will not meaningfully alter the study conclusions. This decision allows us to now accelerate the full development of URG101," commented Urigen's Chief Scientific Officer, Dennis Giesing, PhD.
The URG101-104 study was a pharmacodynamic and safety study investigating the treatment of painful bladder syndrome/ interstitial cystitis (PBS/IC). The cross-over design utilized provided sufficient power to reliably assess treatment effects using modestly sized study cohorts. This study in combination with previous studies has treated a total of 200 subjects to date and further demonstrates URG101 is safe and well-tolerated. A final analysis of the study will be provided later in the quarter.
"These positive clinical trial results replicate and extend my earlier work on URG101. Furthermore, it is exciting to me that these are among the best results that have been obtained in a multi-center trial for PBS/IC. It is important to bear in mind that intravesical therapy is used throughout the country to treat PBS/IC and Urigen is working to standardize this therapy." commented C. Lowell Parsons, M.D., Urigen's Scientific Founder.
The URG101-104 study was a pharmacodynamic and safety study investigating the treatment of painful bladder syndrome/ interstitial cystitis (PBS/IC). The cross-over design utilized provided sufficient power to reliably assess treatment effects using modestly sized study cohorts. This study in combination with previous studies has treated a total of 200 subjects to date and further demonstrates URG101 is safe and well-tolerated. A final analysis of the study will be provided later in the quarter.
"These positive clinical trial results replicate and extend my earlier work on URG101. Furthermore, it is exciting to me that these are among the best results that have been obtained in a multi-center trial for PBS/IC. It is important to bear in mind that intravesical therapy is used throughout the country to treat PBS/IC and Urigen is working to standardize this therapy." commented C. Lowell Parsons, M.D., Urigen's Scientific Founder.