PEREGRINE REPORTS POSITIVE DATA ON HCV IMMUNOTHERAPY

Peregrine Pharmaceuticals has reported preliminary top-line results from a Phase Ib study of its targeted immunotherapy bavituximab in patients with chronic hepatitis C virus (HCV) infection. The repeat-dose, multicenter, open-label study was designed to assess the safety, distribution and pharmacokinetic properties of four ascending dose levels of bavituximab administered as twice-weekly monotherapy in HCV patients.

The results indicate that Peregrine's novel immunotherapeutic drug was generally safe and well tolerated, with no dose-limiting toxicities or serious adverse events reported. The preliminary results also indicate that bavituximab showed positive signs of dose-dependent antiviral activity. These findings set the stage for testing bavituximab in combination with other antiviral therapies.

"As a targeted immunotherapy, bavituximab represents an entirely new approach to treating chronic HCV infection," Eliot Godofsky, principal investigator, said. "Current HCV immunotherapies, such as interferon, act by stimulating a general hyper-immune response, which can cause significant side effects in many patients. In contrast, bavituximab has the potential to specifically target HCV-infected cells for destruction by the immune system."

The study results indicate that 83 percent of patients at the 3-mg/kg dose level showed at least a 75 percent reduction or better in HCV RNA levels, with an average of an 84 percent reduction for the entire cohort. In this cohort, 50 percent of the patients showed signs of greater antiviral activity, with an average HCV RNA load reduction of 1 log. Patients showing signs of antiviral activity typically achieved peak viral load reduction three to seven days after the initial dose. Based on these positive data, Peregrine plans to advance bavituximab into new HCV trials, including additional dosing studies and studies investigating use in combination with other therapies.