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Valium and Prozac Up for Australian Drug Challenge

Valium and Prozac Up for Australian Drug Challenge

Adelaide, Australia: Bionomics Limited (ASX:BNO) today announced the initiation of the Phase I clinical trial for its anti anxiety drug, BNC210. The promising preclinical profile of BNC210 indicates that it is fast-acting and lacks the side-effects seen with current anxiety treatments and may offer the same or greater therapeutic benefit.

The Phase I clinical trial will be conducted in groups of healthy male volunteers at the Pain and Anaesthesia Research Clinic (PARC) within the Royal Adelaide Hospital and is expected to be completed by calendar year end. The primary objective of this trial is to evaluate the safety, tolerability and the pharmacokinetics of BNC210. A secondary objective is the preliminary evaluation of central nervous system effect. The results will enable identification of an appropriate dose range for subsequent clinical studies.

Dr Deborah Rathjen, CEO and Managing Director of Bionomics said “We are very pleased about this early initiation of the Phase I trial of our second drug candidate. Anxiety is a significant market and represents around US$15 billion revenue per year in the global pharmaceutical sector and yet current treatments do not service patients very effectively. We are excited by the prospect that BNC210 may represent an advance in the treatment of both acute and chronic forms of anxiety.”

The potent anxiolytic activity of BNC210 and lack of side effects has been identified in extensive preclinical studies across a broad range of models. Current anxiety treatments, such as benzodiazepines (Valium) and selective serotonin reuptake inhibitors (SSRIs, e.g., Prozac), have various side effects associated with their use. Benzodiazepines offer acute relief to people suffering from anxiety but have sedative, cognitive and motor impairing side effects. In addition, their protracted use can result in tolerance and addiction. SSRIs exhibit slow onset of action (2-4 weeks) and are associated with side effects such as early agitation, gastric disturbances, and sexual dysfunction which preclude their use for the long-term management of anxiety disorders.

The Principal Investigator on the trial is Paul Rolan, Professor of Clinical Pharmacology at the University of Adelaide and a co-founder of PARC. Approval for this trial was granted by the Research Ethics Committee of the Royal Adelaide Hospital in May 2009 and notification given to the Australian regulatory body, the Drug and Safety Evaluation Branch of the Therapeutic Goods Administration (TGA). The trial design is in accordance with the principles of the International Conference on Harmonization (ICH), standards of conduct for clinical trials that are essentially uniform for all the major regulatory agencies world-wide, including the FDA and Australia’s TGA.

Clinical Appendix

Trial Title

The pharmacokinetics and clinical tolerability of ascending single doses of BNC210 in healthy volunteers

Protocol Abbreviated Name:

BNC210.001

Primary Objective:

To determine the general clinical tolerability of ascending single doses of BNC210 and to determine the pharmacokinetics of BNC210

Secondary Objectives:

  • To determine the effects of BNC210 on Bond and Lader visual analogue scales (accepted psychometric methodology by which patients record their perception of their current state), rating neurological and psychiatric symptoms.
  • To identify a dose range to be used in subsequent trials
  • Method: The trial will follow a double-blind placebo-controlled ascending single dose design in healthy volunteers. It is planned that there will be up to 7 cohorts of four participants each (28 participants in total). The number of participants per cohort may be increased if additional safety data is required. The drug will be given orally as a liquid suspension.

    ENDS

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