American Oriental Bioengineering to Initiate a Phase One Clinical Trial in the United States of AOBO-001 Oral Capsule
Bioengineering, Inc. (NYSE: AOB), a
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 Company currently manufactures and markets the oral capsule in
the Cease Enuresis Oral Capsule brand, which was approved by
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
other regions, and all studies will be subject to relevant U.S. FDA
regulations.
Mr.
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
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
the past 12 months to protect the intellectual property of AOBO-001.
About American Oriental Bioengineering, Inc.
American Oriental Bioengineering, Inc. is a
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
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.
SOURCE American Oriental Bioengineering, Inc.