Peregrine compound shows promise as hepatitis monotherapy

The results are from a phase Ia trial evaluating the effect of bavituximab (formerly known as Tarvacin) on viral RNA serum titers when administered as single-dose monotherapy to patients with chronic hepatitis C virus (HCV) infection.

In this analysis, bavituximab showed signs of anti-viral activity at all four study dose levels, as well as showing evidence of a prolonged antiviral effect. These preliminary efficacy data follow positive safety data from the phase Ia study that Peregrine reported in February, indicating that bavituximab was well tolerated, with no dose-limiting toxicities observed.

Peregrine has also announced two additional milestones in the bavituximab HCV clinical program. Firstly, the company has completed the treatment phase of an additional, higher dose cohort that was added to the phase Ia HCV study after the first four cohorts were complete, and secondly, it has begun dosing patients in a new phase Ib repeat dose study in HCV patients.

“This preliminary evidence of anti-viral activity in this first-in-human single dose study of bavituximab is very encouraging,” said Dr Eliot Godofsky, principal investigator of the phase Ia study, and director of the University Hepatitis Center in Sarasota, Florida. “Based on its safety profile to date and these promising signs of anti-viral activity, we look forward to working with Peregrine to assess bavituximab in the repeat dose trial, as well as its potential for use in combination regimens to control and ultimately eradicate HCV.”