Virax takes hep B compound into pre-clinical phase

Melbourne therapeutic vaccine company Virax (ASX:VHL) has taken its hepatitis B treatment into the pre-clinical development phase.

Like the company's existing HIV immunotherapeutic VIR20, the hepatitis B treatment is based on the Co-X-Gene technology platform. "It's analogous to the HIV therapeutic VIR201, but it's tailored as a hepatitis B therapeutic," said CEO Dr David Beames.

The pre-clinical studies will be performed in collaboration with Dr Alfred Prince, who heads the Virology Laboratory at the Lindsley F Kimball Research Institute at the New York Blood Centre.

Beames said the pre-clinical studies would include evaluation of the safety and immunogenicity of the treatment, as well as efficacy studies in animal models including mouse and primate models. "We have learned a lot from the VIR201 HIV program so we expect to move considerably faster in hepatitis B," he said. "I feel very confident that we'll be able to move this one quite quickly."

The company is hoping to apply to the FDA to perform human clinical trials in late 2004 at the earliest. Beames said clinical trials would probably be performed in the USA, in collaboration with Prince.

Beames believes there is a considerable market opportunity for a hepatitis B immunotherapeutic. In the US alone, more than one million patients have chronic hepatitis B. The company is also mulling over the possibility of developing a hepatitis C treatment, he said.

But the next product Virax hopes to move into the pre-clinical phase will be an immunotherapeutic treatment for prostate cancer. Beames said it was likely that an announcement would be made early in the new year about the program.