Avexa HIV antiviral clears another hurdle (Update)Source:...

Avexa HIV antiviral clears another hurdle (Update)

Source: SYDNEY, March 19 AAP

Published: March 19 2007, 5:20PM

Australian biotech company Avexa Ltd has cleared another hurdle in the development of its antiviral HIV drug, with the success of recent trials taking it one step closer to a stake in the multi-billion dollar HIV drug market.
The Melbourne-based company today announced the results of phase IIb trials for apricitabine (ATC), with chief executive Dr Julian Chick saying it had exceeded the company's expectations.
ATC is being developed by Avexa to treat HIV infection in patients with drug-resistant HIV, a problem leading to an increasing number of treatment failures.
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All patients who took part in the 21-day trial showed marked improvement after being given repeated doses of ATC.
The trial included 47 patients, with 17 patients given 600mg doses of ATC, 16 patients receiving 800mg doses and a control group of 14 treated with the commonly used HIV drug, lamivudine.
Patients who received ATC all recorded a more than 85 per cent reduction in the level of HIV in the blood, with one patient experiencing a decrease of 99.7 per cent.
Those in the control group recorded minimal reduction in the level of HIV.
Patients continued to receive ATC for 48 weeks, with some electing to continue treatment into an extension study.
No side-effects had been reported, the company said, and no evidence had been found of an ATC resistant virus emerging during the trial period.
Dr Chick said the success of ATC would be a blessing to HIV sufferers carrying a drug resistant strain of the virus, through improved quality of life and prolonged life expectancy.
"Overall, the results of Avexa's phase IIb clinical trial demonstrate that ATC is a clinically effective antiviral drug that can significantly reduce the replication of the virus in patients infected with drug-resistant HIV," Dr Chick said.
"The benefit to HIV patients is that it gives them another opportunity to reduce the virus level in the blood, therefore prolonging their lives.
"Having another drug like ATC come to market, it gives more patients that ability to live a standard life.
"It takes it from being a fatal disease, to more of a chronic disease."
Dr Chick said worldwide phase III trials will now take place from the end of this year, with the company confident of having ATC on the market by 2010.
"Phase III for HIV drugs has really just been confirmatory. They've had an exceptional success rate, batting 100 for 100," he said, adopting baseball parlance.
Once approved by regulators in key markets such as the US, Europe and Australasia, Avexa then will compete for a slice of the $US6.6 billion ($A8.33 billion) HIV drugs market, of which drugs such as ATC - nucleoside reverse transcriptase inhibitors, or NRTIs - make up around 50 per cent.
Shares in Avexa are in a trading halt and last traded at 68 cents.
ABN Amro Morgans Brisbane director of equities Bill Chatterton, said he expected a "substantial move up" for Avexa shares when the trade halt is lifted.
"The results that have come out of the trials have been really outstanding," Mr Chatterton said.
"I think if you look into past histories, companies that go into Phase III generally speaking go to the market and certainly HIV companies, nearly all of them have gone to the market.
"So it's a very big tick against the their stock.
"I think there will be a substantial move up (in Avexa's share price)."
By Adam Bennett