AVI BioPharma has pursued discovery of a drug against HCV using proprietary Neugene® or Phosphorodiamidate Morpholino Oligomer (PMO) synthetic chemistry. Neugene (PMO) compounds, as a drug class, are considered safe in humans and do not activate complement, alter clotting times, or bind to α-adrenergic receptors (which can produce hypotension) like the phosphorothioate antisense compounds. One PMO, AVI-4065, has been identified as likely to inhibit all 5 genotypes of HCV based on in vitro and in vivo animal models. There are specific data that confirm that AVI-4065 can inhibit HCV RNA dependent PNA polymerase (RdRp encoded in NS5) and the HCV protease (NS3), in a non-competitive inhibitory fashion. The 50 percent Effective Concentration (EC50) is 308 nM, and the efficacy is nearly 100% at 3 μM. These data suggest that AVI-4065 is capable of inhibiting HCV protein translation in a robust manner at concentrations that should be achievable in patients. In rigorous GLP safety pharmacology and toxicity models in a variety of animal species at dosage levels up to 5 times the maximum anticipated human dosage level, inclusive of non-human primates, AVI-4065 was considered safe, well tolerated and without dose-limiting toxicities. Additionally, AVI-4065 Injection was safe and well-tolerated in the three dose-escalating groups of 31 healthy volunteers (Part I) with no serious adverse events. Adverse events that did occur were few, self-limited and mild to moderate and did not require intervention; this observation held true for the first HCV patients receiving AVI-4065 Injection.