Australian biotechnology company, Bionomics Limited (ASX: BNO), announced today that it has completed the GMP (Good Manufacturing Practice) synthesis of its anti-anxiety drug candidate, BNC210. Having now successfully achieved this milestone, Bionomics remains on track to file an Investigational New Drug (IND) application with the US Food and Drug Administration.
Leading contract manufacturing service provider for the pharmaceutical industry Sai Advantium completed Bionomics’ GMP synthesis on time and on budget.
Bionomics will use the material obtained from the GMP manufacture for formal toxicology studies, the final stage of testing prior to anticipated human clinical trials. The same batch will also be used for clinical trials.
Dr Bernard Flynn, Bionomics’ Vice President of Chemistry said, ”Sai Advantium has extensive experience and expertise in taking drug candidates through initial scale-up activities to late stage clinical trials. We are extremely pleased with the progress of BNC210 and look forward to initiating human clinical trials next year.”
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®. The issue is that most of the current anxiety therapeutics are not ideal and have a range of side effects, including sedation and loss of memory.
In order to complete a GMP synthesis, all manufacturing and testing of equipment must be qualified as suitable for use, and all operational methodologies and procedures (such as manufacturing, cleaning, and analytical testing) utilized in the drug manufacturing process must demonstrate that they can perform their purported function.
BNC210 is a novel chemical compound generated from Bionomics’ powerful medicinal chemistry platform technology MultiCore®. 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 animal models for anxiety and related side-effects.
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. Bionomics' most advanced program, BNC105 for the treatment of cancer, is based upon the identification of a novel compound that potently and selectively restricts blood flow within tumours. 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. Bionomics was recently ranked in the top 10 in the Deloitte's Technology Fast 50 Australian technology companies.
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, including, without limitation, statements made regarding BNC105, BNC210 and its' drug development programs 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 further 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 announcement.
FOR FURTHER INFORMATION PLEASE CONTACT:
Dr Deborah Rathjen
CEO & Managing Director
+618 8354 6101/+61418160425
+612 9237 2800/ 0414 388 955