Urigen Announces Early Closure of URG101 Phase II Clinical Trial based on Positive Interim Analysis ResultsBURLINGAME, Calif.--(BUSINESS WIRE)--Apr 7, 2008 - 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.
About Urigen Pharmaceuticals, Inc.
Urigen Pharmaceuticals is a specialty pharmaceutical company dedicated to the development and commercialization of therapeutic products for urological disorders. Urigen's product development programs target significant unmet medical needs and major market opportunities in urology. URG101 targets painful bladder syndrome/interstitial cystitis, which affects approximately 10.5 million men and women in North America. URG301 targets urethritis and acute urgency in patients diagnosed with an overactive bladder. For further information, please visit Urigen's website at http://www.urigen.com.
This press release may contain forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential" or "continue," the negative of such terms, or other comparable terminology. These statements are only predictions. Although we believe that the expectations reflected in the forward-looking statements are reasonable, such statements should not be regarded as a representation by the Company, or any other person, that such forward-looking statements will be achieved. We undertake no duty to update any of the forward-looking statements, whether as a result of new information, future events, or otherwise. In light of the foregoing, readers are cautioned not to place undue reliance on such forward-looking statements. For further risk factors associated with our Company, please review our SEC filings.
Posted: April 2008