Peregrine Completes Patient Enrollment in Randomized Phase II HCV Trial for Bavituximab

Peregrine Pharmaceuticals, Inc. has announced that it has completed patient enrollment in its second randomized Phase II clinical trial for bavituximab.

In this trial, 66 patients with previously untreated genotype-1 hepatitis C virus (HCV) infection were treated with 12 weeks of ribavirin in combination with bavituximab or pegylated interferon alpha-2a.

Bavituximab is a phosphatidylserine (PS)-targeting monoclonal antibody with broad therapeutic potential and also is being evaluated in randomized Phase II trials for second-line and front-line NSCLC and pancreatic cancer, as well as in several investigator-sponsored trials (ISTs) in additional oncology indications.

"Bavituximab has been generally safe and well tolerated in three prior Phase I HCV trials and we look forward to assessing its use in combination with ribavirin for patients chronically infected with HCV," said Joseph S. Shan, M.P.H., Vice President of Clinical and Regulatory Affairs of Peregrine.

Shan continued, "Once all of the patients have completed 12 weeks of therapy, we will determine the proportion of patients achieving an early-virologic response, or EVR, and expect to report data by the end of this year or early next year."

Bavituximab may address a fundamental "immune evasion" mechanism exploited by many infectious pathogens.

A growing body of published data from researchers worldwide shows that bavituximab's PS target, exposed on the surface of cells infected by viruses and protozoan parasites, suppresses the immune system's ability to fight disease.

PS-targeting antibodies such as bavituximab bind to PS and block the immunosuppressive signals created by the target, thereby allowing the immune system to mount a robust immune response against the pathogen.