American Oriental Bioengineering to Initiate a Phase One Clinical Trial in the United States of AOBO-001 Oral Capsule
March 09 2009 - 6:05AM
PR Newswire (US)
NEW YORK, March 9 /PRNewswire-Asia-FirstCall/ -- American Oriental
Bioengineering, Inc. (NYSE:AOB), a China-based pharmaceutical
company dedicated to improving health through the development,
manufacture and commercialization of a broad range of prescription
and over the counter ("OTC") products, announced today that the
Company is initiating a phase one clinical trial of AOBO-001, an
oral capsule developed from traditional Chinese herbal medicine for
the treatment of urinary incontinence (UI) in the United States.
The Company currently manufactures and markets the oral capsule in
China under the Cease Enuresis Oral Capsule brand, which was
approved by China's State Food and Drug Administration ("SFDA") in
2002. UI has a significant impact on its sufferers' quality of life
and is associated with embarrassment, stigma, and shame. According
to Decision Resources, there were 400-500 million sufferers of
urinary incontinence (UI) worldwide in 2007. The U.S. Food and Drug
Administration ("FDA") accepted the Company's Investigational New
Drug (IND) for AOBO-001 in late 2008. The U.S. clinical trial phase
one will commence shortly in order to evaluate the safety of AOBO-
001 in American populations. During the development of AOBO-001 in
the U.S., various preclinical and clinical studies also will be
conducted in China or other regions, and all studies will be
subject to relevant U.S. FDA regulations. Mr. Tony Liu, Chairman
and Chief Executive Officer of American Oriental Bioengineering,
commented, "This is an important milestone in our product
development initiatives. We have observed the efficacy of AOBO-001
on urinary incontinence in Chinese populations since 2002 when we
launched Cease Enuresis Oral Capsules in China. When the first
herbal drug, Veregen, was approved by the FDA in 2006, we further
evaluated the profile of AOBO-001 in a series of laboratory tests.
We believe that AOBO-001 is one of the herbal drug candidates with
great development potential according to the Guidance for Industry,
Botanical Drug Products issued by the FDA in 2004, and we are
particularly excited about the market opportunity for AOBO-001 in
the U.S. Given the history and usage of this prescription UI
treatment, we are optimistic that we can navigate the U.S. FDA
approval process in a time and cost efficient way." About AOBO-001
AOBO-001 oral capsule is developed from traditional Chinese herbal
medicine for the treatment of UI. The selection of indication for
AOBO-001 was based on previous clinical experiences. Potential
effect of AOBO-001 on UI has been evaluated in various in vitro and
in vivo models. Toxicity of this product was assessed through a
series of toxicity studies under the conditions of GLP (Good
Laboratory Practices) in China. AOBO has filed several patents in
the past 12 months to protect the intellectual property of
AOBO-001. About American Oriental Bioengineering, Inc. American
Oriental Bioengineering, Inc. is a China-based pharmaceutical
company dedicated to improving health through the development,
manufacture and commercialization of a broad range of prescription
and over the counter products. Statements made in this press
release are forward-looking and are made pursuant to the safe
harbor provisions of the Securities Litigation Reform Act of 1995.
Such statements involve risks and uncertainties that may cause
actual results to differ materially from those set forth in these
statements. The economic, competitive, governmental, technological
and other factors identified in the Company's filings with the
Securities and Exchange Commission, including the Form 10-K for the
year ended December 31, 2008, may cause actual results or events to
differ materially from those described in the forward looking
statements in this press release. The Company undertakes no
obligation to publicly update or revise any forward-looking
statements, whether because of new information, future events, or
otherwise. DATASOURCE: American Oriental Bioengineering, Inc.
CONTACT: Ashley M. Ammon of Integrated Corporate Relations, Inc.,
+1-203-682-8208 Web site: http://www.bioaobo.com/
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