The use of oral aCD3 Monoclonal antibody (MAb) alone in subjects with hepatitis C is
justified on the basis of scientific and medical reasons. There are data in multiple animal
models that aCD3-alone confers efficacy in models of inflammatory or autoimmune disease and
induces regulatory T cells and immune-modulation as desired in clinical studies. These
observations are reinforced by data in the Phase 1 clinical study showing that aCD3-alone
induced the desired immune-modulation in terms of immunological markers for regulatory T
cells and appropriate rises and declines in certain cytokine levels.