Peregrine's bavituximab demonstrates anti-viral activity in hepatitis C virus trial

By Lisa Kerner

Charlotte, N.C., June 7 - Peregrine Pharmaceuticals, Inc. said top-line results from a phase 1a study of single dose bavituximab (formerly Tarvacin) in patients with chronic hepatitis C virus infection showed signs of anti-viral activity at all four study dose levels.

The company also completed the treatment phase of an additional, higher dose cohort added to the phase 1a hepatitis C study after the first four cohorts were complete.

In addition, Peregrine began dosing patients in a new phase 1b repeat dose study in hepatitis C patients, according to a company news release.

More than 90% of the subjects in the phase 1a study were infected with the genotype 1 form of hepatitis C and had failed or relapsed after receiving standard-of-care treatments.

Bavituximab was administered at 0.1, 0.3, 1 or 3 milligram per kilogram (mg/kg) of body weight.

Among patients treated with the 1mg/kg and 3mg/kg dose levels, 50% achieved a greater than 75% reduction in serum hepatitis C RNA.

"This preliminary evidence of anti-viral activity in this first-in-human single dose study of bavituximab is very encouraging," principal investigator Eliot W. Godofsky said in the release.

"Bavituximab is a potentially novel approach to treating chronic hepatitis C infection, one with a unique mechanism of action that should complement both existing and investigational therapies in development."

Peregrine is a Tustin, Calif., biopharmaceutical company specializing in products for the treatment of cancer and hepatitis C virus infection.

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