PEREGRINE COMPLETES ENROLLMENT IN HEPATITIS C TRIAL

Peregrine Pharmaceuticals has reported that patient enrollment has been completed for the company's Phase Ib repeat-dose, dose-escalation study of bavituximab in patients with chronic hepatitis C virus (HCV) infection. The primary objective of the study is to determine the safety, distribution and pharmacokinetic properties of bavituximab as a multiple-dose monotherapy in HCV patients. Changes in viral load, measured as serum HCV RNA levels, are also being monitored.

Twenty-four patients (four cohorts of six patients each) were enrolled in the study with each cohort scheduled to receive four doses of bavituximab over a 14-day period. Subjects received bavituximab at escalating dose levels of 0.3, 1, 3 or 6 mg per kg of body weight. Patients in all cohorts are being followed for 12 weeks. Final data from the trial will be available when patients complete the 12-week follow-up and data analyses are complete. Initial data from the trial is expected to be available during the first quarter of 2007.

Previously Peregrine reported preliminary results from a Phase Ia single-dose, dose-escalation study of bavituximab in patients who had failed other HCV regimens, which showed that the drug was well-tolerated and demonstrated encouraging signs of antiviral activity.

Bavituximab is the first agent in a new class of anti-phosphotidylserine (PS) immunotherapeutics that targets and binds to cellular components that are normally not present on the outside of cells, but which become exposed on certain virally infected cells and on the surface of enveloped viruses. Bavituximab is a monoclonal antibody that helps stimulate the body's immune defenses to destroy both the virus particles and the infected cells. Similar to their proposed antiviral mechanism, anti-PS agents also bind to phospholipids exposed on tumor blood vessels in all solid cancers tested to date. Bavituximab is in Phase I clinical trials for the treatment of solid tumor cancers in the U.S. and a combination trial with chemotherapy in cancer patients in India will soon begin.