Virax soars on positive Phase II results

Virax's share price (ASX:VHL) soared 28 per cent today on heavy trading after the company released good results for its HIV immunotherapy Phase IIa clinical trial.

"We have a very promising material result in the first stage of our assessment of the effectiveness of VIR201. It builds strongly on the safety profile which was established through the Phase I trial, the results of which were announced earlier this year," said CEO David Beames.

The trial was run as an extension to the Phase I trial, which was completed in February this year. In the first study, patients were given three doses of the immunotherapy VIR201 to evaluate the safety of the treatment, but were not taken off standard highly active anti-retroviral therapy (HAART). The treatment was demonstrated to be safe, but little information on the efficacy of the therapy could be gleaned from the trial.

The second trial involved participants in the original trial receiving another dose of the therapy prior to going off the HAART regime. The viral load was then monitored for 20 weeks.

The results showed that VIR201 performed better at controlling the patients' viral load than placebo, according to Prof David Cooper, director of the Australian National Centre for HIV Epidemiology and Clinical Research (NCHECR), which coordinated the trial.

"This latest data provides a promising preliminary indication which merits further development," Cooper said.

"An effective immune-based therapy could enable patients to reduce their reliance on other HIV drugs (highly active anti-retroviral therapy or HAART). HAART drugs, not withstanding their expense, impact on patients' quality of life due to serious side-effects, and the need for strict adherence."

Beames said the results were very exciting for the company, and provided a critical clinical milestone for the technology.

"It clears the way for further development of VIR201 and bolsters our confidence in the promise [of the Co-X-Gene technology] for other applications," he said. "It also provides a credible and attractive story for further capital raising and partnering."

Beames said the next step would be to plan larger Phase II studies for the treatment, although specific details had not yet been worked out.

"We need to consider the product development path, as opposed to an academic investigation," he said. The company is working with US consultants Clearview Projects to identify potential partners for continued development of the technology, although further trials are not contingent on partnering.

In the mean time, Virax is going ahead with pre-clinical programs for prostate cancer and hepatitis B treatments utilising the Co-X-Gene platform.

Clinical investigators at the (NCHECR) have submitted an abstract on the results of the Phase IIa study to an international symposium to be held early next year and plan to publish the data in an appropriate peer-reviewed journal.

At the time of writing, shares in Virax were trading at AUD$0.34.