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Avexa Reports Positive Phase IIb Result

und 1.4 million people in North America and around 2.2 million people in Europe have HIV.

Once on therapy, patients with HIV will typically take a minimum of 3 drugs daily in combination. This may increase as a patient progresses into 2nd and 3rd line therapy or into salvage therapy, when patients develop what is commonly referred to as AIDS. Second line patients are defined as patients who show resistance to at least one class of HIV drugs, while 3rd line and salvage patients typically have resistance to multiple drugs and drug classes. Avexa aims to position ATC as the NRTI of choice for treatment of patients in 2nd and 3rd line therapy and salvage therapy, as well as the growing number of treatment naive patients presenting with HIV virus resistant to current front line therapies. In 2005 HIV drugs generated sales globally of USD $6.6 billion, with NRTIs representing greater than 50% of the overall market.

Avexa Limited is a Melbourne-based biotechnology company with a focus on research and development of drugs for the treatment of infectious diseases, in particular diseases which have a significant unmet medical need. Avexa has dedicated resources and funding for key projects including antiviral drugs for HIV and an antibiotic alternative for antibiotic-resistant bacterial infections. The Company's lead program is apricitabine (ATC) which has recently successfully completed the 21 day dosing of its Phase IIb trial. The Company continues to progress ATC towards Phase III trials.

Technical Data

Trial Design

AVX-201 is a randomised, double blind study of two doses of ATC compared to lamivudine (3TC) in treatment-experienced HIV-1 infected patients with the M184V mutation. Patients were randomised to receive 600mg or 800mg ATC twice daily, or 3TC twice daily, for 21 days, in a blinded fashion. The primary endpoint of the study is the change in the amount of virus in the blood (viral load) after 21 days treatment.

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