News

BNC105 US RENAL CANCER TRIAL INITIATED

• First three US trial sites now open for enrolment
• Up to 12 clinical trial sites planned, with an anticipated 152 patients to be enrolled
• Initial data from study anticipated by end 2010

27 January 2010; Adelaide, Australia: Bionomics Limited (ASX: BNO) today announced that a clinical trial of BNC105 in patients with renal cell carcinoma has been initiated in three clinical sites in the US.

The trial, which is being conducted by the Hoosier Oncology Group, is now open to enrolment at the Baylor Sammons Cancer Centre, Dallas, Texas; Indiana University Melvin and Bren Simon Cancer Centre, Indianapolis; and the Cancer Treatment and Research Centre, University of Texas, San Antonio, Texas.

Up to 12 sites are anticipated to become involved in the trial across the US and a total of 152 patients are anticipated to be enrolled in the trial.

The trial will determine whether BNC105 is effective in the treatment of progressive metastatic renal cell carcinoma, either in combination with or following Afinitor® (also known as Everolimus) treatment in patients who have disease progression following treatment with tyrosine kinase inhibitors such as Sutent® or Nexavar®.

Trial Principal Investigator Dr Thomas E Hutson of the Baylor Sammons Cancer Centre/Texas Oncology commented "The mechanism of action of BNC105 provides an innovative approach to the treatment of solid tumours, including metastatic renal carcinoma, by attacking established tumour vasculature. It is particularly exciting to be conducting a trial which has the potential of creating a new paradigm for the treatment of renal cancer".

Renal cancer accounts for 2-3% of human malignancies and accounts for over 85% of kidney cancers. Every year, approximately 200,000 cases are diagnosed worldwide, with 55,000 people diagnosed in the USA. The five year survival rate for patients with metastatic disease is less than 2%. Kidney cancer is asymptomatic, and in 40% of cases is diagnosed at an advanced stage.

Dr Deborah Rathjen, Bionomics' CEO & Managing Director commented "We are pleased to be working with such an experienced clinical consortium as the Hoosier Oncology Group to conduct this trial across multiple sites throughout the US. Metastatic renal cancer has a poor prognosis and there exists a real need for new therapies despite relatively recent advances in treatment. It is encouraging that a renal cancer patient enrolled in the Phase I study of BNC105 conducted in Australia under an IND application to the US FDA showed clinical benefit".

Dr Rathjen further commented "In addition to the potential clinical benefits of BNC105, we believe that renal cell cancer offers a strong market opportunity for BNC105 if successfully developed. Worldwide sales of Sutent® were US$847 million in 2008, whilst reported sales of Nexavar® in 2008 were US$677.8 million. Sales projections for Afinitor®, which gained marketing approval in the US and Europe in 2009 for the treatment of renal cancer, exceed US$500 million."

Further details of the trial are shown below in the clinical appendix and can also be found at www.clinicaltrials.gov which provides details of all approved clinical trials being conducted in the US.

FOR FURTHER INFORMATION PLEASE CONTACT:

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

Clinical Appendix

Study Title: BNC105P in combination with Afinitor® (Everolimus)/following Everolimus for progressive metastatic clear cell renal cell carcinoma.

Study Design: This is a trial to evaluate the combination of BNC105 and Everolimus for the therapy of progressive clear cell RCC following prior treatment with Tyrosine Kinase Inhibitor(s) (Arm A). Additionally, patients progressing on Everolimus alone will be offered BNC105, which will provide an opportunity to evaluate the activity of monotherapy with BNC105 (Arm B). Patients will be randomized 1:1 to either Arm A or Arm B of the study. A total of 152 patents are expected to be enrolled in the trial.

Patients administered BNC105 will be treated in repeating 21-day cycles, each cycle consisting of two doses administered one week apart (i.e., on Days 1 and 8). Everolimus is orally administered as a 10 mg tablet once a day. The trial will open in up to 12 U.S. trial sites and will be conducted by the Hoosier Oncology Group. The trial is being run under a U.S. FDA Investigational New Drug application.

Study Summary: The purpose of this study is to determine whether BNC105P in combination with/following Everolimus is effective in the treatment of progressive metastatic renal cell carcinoma following prior tyrosine kinase inhibitors.

Endpoints:
PRIMARY

• Improvement in 6-month Progression Free Survival (PFS) with the addition of BNC105 to Everolimus.

SECONDARY
To determine:

• Response rate with combination therapy compared to everolimus alone.
• PFS with BNC105 alone in patients progressing on everolimus.
• The adverse events of the Everolimus and BNC105 when administered as a combination or sequential regimen.
• Overall survival.

EXPLORATORY

• To determine the correlation of PFS with biomarkers.

About Bionomics Limited

Bionomics (ASX: BNO) 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, epilepsy and multiple sclerosis. BNC105, which is undergoing clinical development for the treatment of cancer, is based upon the identification of a novel compound that potently and selectively restricts blood flow within tumours. A clinical program is also underway for the treatment of anxiety disorders based on BNC210 which exhibits strong anxiolytic activity without side effects in preclinical models. Both compounds offer blockbuster potential if successfully developed.

Bionomics' discovery and development activities are driven by its three 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® 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

About the Hoosier Oncology Group

The Hoosier Oncology Group, which is headquartered in Indianapolis, consists of a working association of over 400 dedicated community and research centre physicians and clinical research practitioners across the United States. It has successfully leveraged this network to conduct cancer clinical trials since its creation in 1984.

About BNC105

BNC105 is a Vascular Disruption Agent (VDA) that acts to rapidly shut down the blood supply within a tumour. It thereby "starves" the tumour of the oxygen and nutrients it needs to survive. VDAs have significant clinical potential in the treatment of cancer, as they may potentially be applied across a very wide variety of cancer types, including colon, lung and breast cancers. The market potential for VDAs has been estimated at approximately US$5 billion annually (ASInsights, 2003).

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 BNC105, 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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