Press Releases

Sydney, Nov 22, 2007 (ABN Newswire) - Shares in biotechnology company Bionomics Limited (BNO) climbed 7% to 37.5 cents after it said on Thursday its application to the US Food and Drug Administration (FDA) for its new anti-cancer compound has passed review.

Trading volumes were thin, indicating investor caution as the process has a long way to go before it receives final approval for market distribution.

The South Australian based company filed an Investigation New Drug (IND) application with the FDA in order to test the new drug on humans.

This means the biotech can start clinical trials on voluntary humans after it proved its efficacy and safety in animals.

The compound, BNC105 is a new type of anti-cancer drug called a Vascular Disruption Agent. It acts by shutting down the blood supply within a tumour, starving the tumour of nutrients.

 'BNC105 is a proprietary molecule discovered by Bionomics and it is immensely satisfying to see it move to this next stage of development," Dr Gabriel Kremmidiotis of Bionomics VP Discovery Research said.

"We are very encouraged by the results of the preclinical studies of BNC105 which has demonstrated efficacy in models of breast, lung, prostate and colon cancers," he added.

Lodging the IND application is the first step in the lengthy process of new drug approvals.

In a statement to the market Bionomics said it will conduct the first clinical trial on BNC105 in Australia with plans to conduct further clinical trials in the US and Australia.

Further details will be provided upon commencement of the clinical trial, Bionomics said.

BNO is a biotechnology company creating small molecule drugs to treat cancer and disorders of the central nervous system. The company has drug discovery programs in four therapeutic areas: Cancer,  Multiple Scelrosis, Anxiety/Epilepsy and Cancer.

Bionomics has market capitalisation of about $73 million.

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