Message #2 From:
NewsBot Date: March 12, 2008 01:23:09 PM
Urigen Announces Positive Phase II Clinical Trial Results with URG101
URG101 Significantly Reduces Painful Bladder Syndrome/Interstitial
Cystitis Symptoms Following A Single Dose
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 (PBS/IC)
“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.
Forward-Looking Statement
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.
Urigen Pharmaceuticals, Inc. Martin E. Shmagin, 650-259-0239 Chief
Financial Officer www.urigen.com or Thomas
Redington 203-222-7399 212-926-1733 www.redingtoninc.com
