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Ironwood Begins Phase I Trial of Investigational IW-2143 Anxiety Drug in US



Ironwood Begins Phase I Trial of Investigational IW-2143 Anxiety Drug in US

ADELAIDE, Australia, Dec. 21, 2012 (GLOBE NEWSWIRE) -- Bionomics Limited
(ASX:BNO) (ADR:BMICY) has been advised by its licensee Ironwood
Pharmaceuticals Inc (Nasdaq:IRWD) that, following the submission of an
Investigational New Drug (IND) application to the US Food and Drug
Administration (FDA) last month, the planned Phase I clinical trial of the
investigational anti-anxiety drug candidate IW-2143 (BNC210) has begun in the
US.

The trial is designed to assess the safety and pharmacokinetics of IW-2143 in
healthy volunteers, using single and multi-dose administration.

"This is the first US clinical trial of IW-2143 and this news is welcomed by
Bionomics as a strong signal of the progress being made by Ironwood in moving
ahead with the study of IW-2143," said CEO and Managing Director of Bionomics
Dr Deborah Rathjen. "As this trial progresses it is anticipated that a US$2
million milestone payment to Bionomics by Ironwood will be triggered."

Ironwood is responsible for developing and, if approved, commercialising
IW-2143 and related compounds, including paying for the costs of clinical
development.

In the US, anxiety disorders affect approximately 40 million Americans each
year and while there are therapies available, there remains significant unmet
need.

About IW-2143 (BNC210)

IW-2143 is a small molecule discovered by Bionomics through a targeted
medicinal chemistry program. Data from several preclinical studies indicated
that IW-2143 may have anti-anxiety activity and appeared to promote neurite
outgrowth in vitro. In a phase I study that included placebo and lorazepam
control arms, healthy volunteers who took IW-2143 did not appear to experience
impaired attention. Electroencephalography (EEG) data gathered on healthy
subjects dosed with IW-2143 in the study provided information about the
pharmacodynamic effect of the molecule.

About Bionomics Limited

Bionomics (ASX:BNO) is an Australian based international biotechnology company
which discovers and develops innovative therapeutics for cancer and diseases
of the central nervous system. Bionomics has small molecule product
development programs in the areas of cancer, anxiety, memory loss and
autoimmune disorders, several of which are in or approaching clinical
development stage. Its oncology approach includes cancer stem cell
therapeutics as well as vascular disruption in solid tumours.

Bionomics' discovery and development activities are driven by its four
proprietary technology platforms: Angene®, a drug discovery platform which
incorporates a variety of genomics tools to identify and validate novel
angiogenesis targets (involved in the formation of new blood vessels);
MultiCore®, a diversity orientated chemistry platform for the discovery of
small molecule drugs; ionX® , a set of novel technologies for the
identification of drugs targeting ion channels for diseases of the central
nervous system; and CSC Rx Discovery™, which identifies antibody and small
molecule therapeutics that inhibit the growth of cancer stem cells. These
platforms drive Bionomics' pipeline and underpin its established business
strategy of securing partners for its key compounds.

www.bionomics.com.au

Factors Affecting Future Performance

This announcement contains "forward-looking" statements within the meaning of
the United States' Private Securities Litigation Reform Act of 1995. Any
statements contained in this presentation that relate to prospective events or
developments, including, without limitation, statements made regarding
Bionomics' development candidates BNC105, IW-2143(BNC210), our acquisition of
Eclipse Therapeutics and ability to develop products from their platform, its
licensing deal with Ironwood Pharmaceuticals, drug discovery programs and
pending patent applications are deemed to be forward-looking statements. Words
such as "believes," "anticipates," "plans," "expects," "projects,"
"forecasts," "will" and similar expressions are intended to identify
forward-looking statements.

There are a number of important factors that could cause actual results or
events to differ materially from those indicated by these forward-looking
statements, including risks related to our available funds or existing funding
arrangements, a downturn in our customers' markets, our failure to introduce
new products or technologies in a timely manner, Ironwood's decisions to
continue or not continue development of IW-2143, regulatory changes, risks
related to our international operations, our inability to integrate acquired
businesses and technologies into our existing business and to our competitive
advantages, as well as other factors. Results of studies performed on
competitors products may vary from those reported when tested in different
settings.

Subject to the requirements of any applicable legislation or the listing rules
of any stock exchange on which our securities are quoted, we disclaim any
intention or obligation to update any forward-looking statements as a result
of developments occurring after the date of this presentation.

CONTACT: Bionomics Limited
         Dr Deborah Rathjen
         CEO & Managing Director
         +618 8354 6101 /
         0418 160 425
         drathjen@bionomics.com.au
        
         Monsoon Communications
         Rudi Michelson
         +613 9620 3333
         rudim@monsoon.com.au
        
         The Trout Group
         Lauren Glaser
         +1 646 378 2972
         lglaser@troutgroup.com
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