The study was designed to assess the safety and pharmacokinetic properties of ascending dose levels of bavituximab administered as monotherapy in patients with chronic HCV (hepatitis C virus) infection. Other study objectives included evaluation of anti-viral activity as measured by changes in serum HCV virus levels and an exploratory analysis of changes in serum cytokine levels as a measure of bavituximab’s ability to stimulate certain components of the immune system.
Anti-viral activity (decline of greater than or equal to 0.5 log10 reduction in HCV RNA) was observed at all dose levels and was most consistent in patients receiving 3mg/kg of bavituximab. In this cohort, 83% of the patients demonstrated anti-viral activity. An assessment of the cytokine profile in this cohort also suggests bavituximab induces a pro-inflammatory cytokine profile, defined as an increase in the ratio of TNF alpha and TGF beta.
Steven King, president and CEO of Peregrine, said: “Meeting all of the objectives of this phase l trial was an important milestone for the bavituximab HCV program. We are particularly pleased with bavituximab’s positive safety profile at all doses tested, its predictable and consistent pharmacokinetic characteristics, and the signs of anti-viral activity and immune system stimulation that were observed. Based on these results, we have been able to identify a target dose range of 3mg/kg for future clinical studies.”