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.
