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BIONOMICS’ ANXIETY DRUG CANDIDATE APPROVED TO ENTER HUMAN CLINICAL TRIAL

21-May-2009

Adelaide, Australia: Australian biotechnology company Bionomics Limited (ASX:BNO) today announced that its lead anti-anxiety compound, BNC210, has successfully passed review and is approved to enter human clinical trials.

With the success of its clinical trial application and ethics approval now in place, Bionomics will commence the first clinical trial on BNC210 in Adelaide, Australia at the Royal Adelaide Hospital. Professor Paul Rolan, Professor of Clinical Pharmacology at the University of Adelaide will be Principal Investigator.

Anxiety is a common debilitating condition that affects 19 million patients in the US alone, and has an estimated market value US$5-$12 billion worldwide. Many of the largest blockbuster drugs are for treating anxiety including Valium, Prozac, Paxil, Buspar and Zoloft.

Professor Rolan commented "There have been no fundamentally new and effective treatments for anxiety for decades. Of the treatments we do have, many patients are burdened by side-effects. BNC210 appears to be entirely novel in its action and remarkably free of the sedation associated with other treatments for anxiety. I am delighted to be leading this first study of BNC210 in man".

Preclinical data shows that in animals BNC210 is able to reduce anxiety without the common side effects of current anxiety drugs including drowsiness, impairment of memory and motor function. In addition, BNC210 was shown to be fast-acting and effective with a single daily oral dose.

Bionomics' CEO & Managing Director Dr Deborah Rathjen said "The clinical trial approval marks a major achievement for Bionomics, which in the space of two years, has progressed two drug candidates to clinical trial".

"From a commercial stand-point, I believe BNC210 is a key asset in to our pipeline. The market for anxiety drugs is enormous and BNC210 appears to have key features of competitive advantage when compared with existing treatments. We are excited by the prospect that BNC210 may represent an advance in the treatment of both acute and chronic forms of anxiety" Dr Rathjen further added.

Dr Gabriel Kremmidiotis, Bionomics VP Discovery Research said, "BNC210 is a novel compound. It was the best performing anxiety drug candidate out of a focussed library of compounds that were synthesized, evaluated and tested in a range of small animal models. It is immensely satisfying to see it move to this next stage of development. We are very encouraged by the results of our preclinical studies of BNC210 which has demonstrated efficacy across a broad range of models of anxiety".

The primary goals of the first clinical trial will be to evaluate the safety and tolerability of BNC210 and its pharmacokinetics.
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FOR FURTHER INFORMATION PLEASE CONTACT:
Bionomics Limited

Dr Deborah Rathjen
CEO & Managing Director
+618 8354 6101 / 0418 160 425
drathjen@bionomics.com.au

About Bionomics Limited

Bionomics (ASX:BNO) discovers and develops innovative therapeutics for anxiety and diseases of the central nervous system. Bionomics has small molecule product development programs in the areas of anxiety, anxiety, epilepsy and multiple sclerosis. Bionomics' discovery and development activities are driven by its three technology platforms: Angene®, the company's angiogenesis target and drug discovery platform, incorporates a variety of genomics tools to identify and validate novel angiogenesis targets. MultiCore® is Bionomics' proprietary, diversity orientated chemistry platform for the discovery of small molecule drugs. ionX® is a set of novel technologies for the identification of drugs targeting ion channels for diseases of the central nervous system.

For more information about Bionomics, visit 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 press release that relate to prospective events or developments 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 the clinical evaluation of BNC210, 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, 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. 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 press release.

 

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