URG101 Significantly Reduces Painful Bladder Syndrome/Interstitial Cystitis Symptoms Following A Single DoseBURLINGAME, Calif., Mar 12, 2008 (BUSINESS WIRE) -- Urigen Pharmaceuticals, Inc. (OTCBB: URGP), http://www.urigen.com,
today announced positive results from a multi-center, double-blind,
placebo-controlled, crossover designed clinical trial of URG101 in
patients with Painful Bladder Syndrome / Interstitial Cystitis
"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
-- 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
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.
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as "may," "will," "should," "expect," "plan," "anticipate," "believe,"
"estimate," "predict," "potential" or "continue," the negative of such
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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.
SOURCE: Urigen Pharmaceuticals, Inc.
Urigen Pharmaceuticals, Inc.
Martin E. Shmagin, 650-259-0239
Chief Financial Officer