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Urigen Announces Early Closure Of URG101 Phase II Clinical Trial Based On Positive Interim Analysis Print E-mail
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Health and Medical News - Urology & Nephrology
Wednesday, 09 April 2008



Urigen Pharmaceuticals, Inc. (OTCBB:URGP), http://www.urigen.com, announced the early closure of the URG101-104 study thanks to positive, statistically meaningful interim study results in both the primary and all secondary endpoints. The top line results of the interim study 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 preceding studies has treated a total of 200 subjects to date and further demonstrates URG101 is safe and well-tolerated. A final study of the study will be provided later in the quarter.

"These positive clinical trial results imitate and enlarge my before 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 meaningful 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 devoted to the development and commercialization of therapeutic products for urological disorders. Urigen's product development programs goal meaningful unmet medical requires 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 info, please visit Urigen's website at http://www.urigen.com.

Forward-Looking Statement

This press release may contain forward-looking statements. In some cases, you can identify forward-looking statements by terminology like "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 task to update any of the forward-looking statements, whether as a result of new info, 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.

http://www.urigen.com



 
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