Peregrine Pharmaceuticals Inc. (PPHM) said it has initiated a mid-stage clinical trial in patients with previously untreated genotype-1 hepatitis C virus (HCV) infection.
The company said the trial will determine the early virologic response (EVR) rate of patients after 12 weeks of therapy with Peregrine's bavituximab, a phosphatidylserine (PS)-targeting monoclonal antibody with immune-modulating potential, in combination with the antiviral drug ribavirin versus standard of care, pegylated interferon alpha 2a and ribavirin.
The primary endpoint of the study is the proportion of patients achieving early virologic response (EVR), an early predictor of which patients are likely to clear virus with continued treatment. Secondary endpoints include safety, tolerability and HCV viral kinetics.
Peregrine expects to complete enrollment shortly in an ongoing Phase Ib HCV trial and report data by mid-year.
by RTT Staff Writer
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