Australian biotechnology company, Bionomics Limited has completed the GMP (Good Manufacturing Practices) synthesis of its promising new cancer drug candidate, BNC105. Bionomics is now using this material 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.

SAFC Pharma, a leading contract manufacturing service provider for the pharmaceutical industry, completed on time and on budget the synthesis. With this milestone, Bionomics remains on track to file an Investigational New Drug (IND) application with the US Food and Drug Administration and to commence human trials of BNC105 later in 2007.

SAFC completed manufacturing of 1.5 kg of BNC105P, the pro-drug form of BNC105, at a purity of 99.98 per cent.

Dr Bernard Flynn, Bionomics' vice president of chemistry said, "One of the competitive advantages of BNC105 is that the chemical synthesis is very short. It consists of only 6 simple steps, of which only the last 3 are required to be performed under GMP. This means that the cost of goods will be low in comparison to many other drugs in the class."

"The purity achieved also significantly exceeded our specifications. This is of great benefit, because it helps to simplify our analytical work and reduces risk in the toxicology studies. The success of this scale-up synthesis is also a further validation of our drug discovery platform, MultiCore, demonstrating that not only is this platform able to expedite the discovery of new drug candidates but that the candidates it generates are also amenable to scale-up and manufacture in a pure form and in a cost effective and timely fashion." said Dr Flynn.

BNC105 is a novel chemical compound discovered by Bionomics that acts as a highly potent Vascular Disruption Agent (VDA).

VDAs are a new class of anti-cancer agent that kills tumours by starving them of blood flow. As many as 85 per cent of human cancers are potentially treatable by VDAs. Their market potential has been estimated as US$5 billion per year or more.

Bionomics has shown that in comparison to other VDAs in development, BNC105 has several significant therapeutic advantages. It has a much larger safety margin than competitor's products and is capable of killing tumours when used as a single-agent.