5 October 2010European Approval Granted for Two Phase Ib...

5 October 2010
European Approval Granted for Two Phase Ib Clinical Trials of BNC210


First trial will evaluate the potential for BNC210 to relieve panic attacks and reduce symptoms of anxiety.

Second trial will compare BNC210 with Lorazepam, particularly the
potential for BNC210 to deliver the efficacy without the memory loss side effects of many currently marketed anxiety drugs.

Positive data from the trials will indicate BNC210 has a clear competitive advantage over current anxiety and panic attack drugs, including billion dollar products like Xanax and Valium


5 October 2010; Adelaide, Australia: Bionomics Limited (ASX: BNO) today announced approval from the French Medical Agency AFSSAPS (Agence Francaise de Securite
Sanitaire des Produits de Sante) and the Ethics Committee of the Strasbourg Hospital, CPP (Comit de Protection des Personnes), to perform two advanced Phase I clinical trials with BNC210, Bionomics compound in development for the treatment of anxiety and depression.


The first of the newly approved clinical studies will examine whether BNC210 reduces panic and anxiety symptoms induced by pharmacological means in healthy volunteers. The peptide CCK-4 will be used to induce symptoms of panic and anxiety. Bionomics has previously reported that BNC210, in a rodent model of CCK induced anxiety, overcomes the effects of CCK. These results were recently presented at a major international conference, the
European Congress of Neuropsychopharmacology (ECNP).


The second trial will evaluate the effects of BNC210 on the brain using electroencephalograph (EEG) and quantitative assessments of memory function. In this trial the effects of BNC210 will be compared with Lorazepam, a drug closely related to Valium, which is known to have the adverse side effect of causing memory impairment.


Both trials will be conducted in France by Forenap Pharma, an International Contract Research Organization (CRO), which has 20 years experience in early drug development
and conducting studies into the effects of drugs on the central nervous system. Bionomics subsidiary, Neurofit SAS, is the designated sponsor of the trials. Forenap has the capacity to run both clinical studies in parallel and it is anticipated that data from both trials will be
available in the first quarter of 2011.


Dr Deborah Rathjen CEO & Managing Director of Bionomics commented Todays announcement heralds a major step forward in the development of BNC210 for the treatment
of anxiety disorders. Our previous Phase I clinical trials indicated that BNC210 was safe and well tolerated and with no indication, even at high dosage levels, of the side effects found in many currently available drugs used to treat anxiety.


Whilst these new clinical trials will be conducted in healthy volunteers, both studies have been specifically designed to demonstrate the value of BNC210 as an innovative treatment for anxiety and depression.


Panic disorder is a common type of anxiety disorder experienced by 1.7% of the population. It is currently treated with benzodiazepines such as Valium and Xanax. Forbes.com recently reported that Xanax, the first drug approved for the treatment of panic attacks, is the most
prescribed psychiatric drug in the US, with one prescription issued every second in 2009.


Bionomics trials of BNC210 will investigate the potential of BNC210 to relieve symptoms of panic and anxiety. They will also evaluate the brain effects of BNC210 compared to Lorazepam, another benzodiazepine, which is known to impair memory. The potential
commercial implications of positive results in these two trials cannot be overstated Dr Rathjen further commented.


Details of the approved European trials are shown below in the Clinical Appendix following this announcement.


Bionomics also has two Phase II clinical trials in progress for its solid tumour drug candidate, BNC105. Results from the trials in renal cancer and the asbestos-related cancer mesothelioma are expected in early 2011.


FOR FURTHER INFORMATION PLEASE CONTACT:

Bionomics Limited
Dr Deborah Rathjen
CEO & Managing Director
+6I8 8354 6I0I / 04I8 I60 425
[email protected]