Virax successfully completes HIV clinical trial

Virax has announced the successful completion of its Phase I/IIa trial for its HIV immune-based therapeutic VIR201, with the last of 34 patients completing the six-month series of injections and blood tests.

The trial was designed to examine safety and immunogenicity of the drug, which primes the patient's immune system to better fight the virus by activating a specific T-cell response. The drug was designed using Virax's proprietary Co-X-Gene platform technology, and uses a modified fowlpox virus to co-deliver both HIV antigen genes and the gene for gamma-interferon.

"So far there has been an initial review of the raw safety data from the Data Safety Monitoring Committee. Preliminary indications are that the product has been well tolerated," said Virax CEO David Beames. A more detailed report will be provided to the company in the next few weeks.

"In particular we'll be really looking forward to the immunogenicity results," Beames said. "Theory and the pre-clinical results suggest that we should get an increase in HIV specific T-cells."

Further safety follow-ups are still in progress for some of the patients, and a 20-week extension trial will be performed on patients to look at the effects of the drug after the patient is taken off anti-retroviral treatment. Data from this study is expected to be available at the end of 2003.

The trial was conducted by the University of NSW-based National Centre for HIV Epidemiology and Clinical Research.