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Avexa Reports Positive Phase IIb Result

VICTORIA, Australia--(BUSINESS WIRE)--Mar 20, 2007 - Australian biotechnology company Avexa (ASX:AVX) today announced highly successful results from its Phase IIb trial for apricitabine (ATC). ATC is Avexa's novel nucleoside reverse transcriptase inhibitor (NRTI) being developed for the treatment of HIV infection in patients with drug-resistant HIV.

The Phase IIb trial compared the effectiveness of ATC in reducing the viral load of patients with drug-resistant HIV with the effectiveness of lamivudine (3TC), a leading NRTI in widespread use. A total of 47 patients completed 21 day dosing. Of these 17 patients received 600 mg doses of ATC, 16 received 800 mg doses of ATC and the control group of 14 patients were treated with 3TC.

The results for patients in both ATC cohorts exceeded the Phase IIb trial primary endpoint by a substantial margin. Patients who received ATC achieved on average a reduction of greater than 0.8 log(10) (85%) in the level of HIV in the blood after 21 days treatment compared to a reduction of less than 0.03 log(10) in patients treated with 3TC. Nine patients achieved a greater than 1.5 log(10) (97%) reduction after 21 days, with 3 patients achieving a reduction of over 2.0 log(10) (99%). Remarkably, one patient achieved a decrease in the amount of virus of more than 2.5 log(10) (99.7%) after 21 days on ATC. Patients with the highest degree of drug resistance still achieved a significant benefit from treatment with ATC. The demonstration of superior activity in this study indicates that ATC will be an effective antiviral drug for the treatment of many drug-resistant patients, including even those most highly resistant.

"This is a fantastic result for Avexa," stated CEO Dr Julian Chick. "The positive result allows us to continue to progress ATC into Phase III trials and towards commercialisation. The team at Avexa has done a great job and these excellent results show that their
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