Urigen Announces Positive Phase II Clinical Trial Results with URG101
"Urigen is pleased to announce these positive results from our URG101-104 Phase II trial. We believe this data confirms earlier studies and demonstrates URG101 significantly reduces PBS/IC symptoms following a single dose of the product. First dose symptom relief can be important for many patients that experience periods of acute symptom exacerbation" stated Dennis Giesing, PhD, Chief Scientific Officer of Urigen Pharmaceuticals.
URG101 Phase II Trial Results
URG101, an investigational bladder instillation, is a proprietary pharmaceutical treatment comprised of lidocaine and heparin. This Phase II study was a multi-center, double-blind, randomized, placebo-controlled, cross-over study comparing URG101 to placebo. The results reported today are based upon an interim analysis of 21 completed patients. The trial design allows up to 50 patients to be enrolled in the study. Additional analyses are ongoing, the results of which will become available over the next weeks at which time a decision will be made regarding enrollment of additional patients. Primary and secondary efficacy measurements in the study demonstrated that URG101 was significantly better than placebo. Top line data analysis findings include:
-- Primary Endpoint - Improvement in Average Daytime Pain (p=0.03).
-- Secondary Endpoints - Improvement in Daytime Urgency (p=0.03) and Total Symptom Score (p=0.03). In addition, patients reported improved symptom relief with URG101 as measured by PORIS (p=0.01).
About Painful Bladder Syndrome/Interstitial Cystitis (PBS/IC)
Painful Bladder Syndrome/Interstitial Cystitis is a recognized medical condition with increased frequency of diagnosis. PBS/IC is characterized by bladder pain, urinary urgency and nocturia where few IC treatments exist and no approved therapies are available for PBS. Today, there are an estimated 10.5 million women and men in North America who suffer from PBS/IC.
Urigen will conduct a live webcast to provide a complete review of the Company's development programs at 11:00 a.m. EST on Thursday, March 13, 2008. To access an audio webcast of this event, please go to the link on Urigen's website at http://www.urigen.com five minutes in advance of the start time. Questions will be taken by email during the live webcast. A replay will also be available on demand, starting four hours after the webcast's conclusion and until March 31, 2008.
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. URG201 targets male hypogonadism, which has been estimated to effect 13 million men in the United States. Urigen's URG301 project 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: March 2008