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Amdoxovir® (AMDX, DAPD) - DAPD is a nucleoside analog prodrug that is deaminated by adenosine deaminase to its 2'-deoxyguanosine analog, DXG. The triphosphate form of DXG is a potent and selective inhibitor of HIV-1, including drug resistant viruses harboring clinically relevant mutations. It is also active against HIV-2 and hepatitis B virus. To date, 206 subjects have safely received DAPD in seven Phase I and II studies. DAPD is currently in advanced Phase II clinical trials. DAPD has an excellent toxicity profile in subjects receiving treatment for up to 96 weeks and is very effective at decreasing viral load in HIV infected individuals, including those with extensive nucleoside reverse transcriptase inhibitor (NRTI) mutations. We estimate that this innovative technology has a high probability of success towards a US NDA submission in 2011.
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