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news.Peregrine Pharmaceuticals has concluded patient recruitment in a Phase Ib dose escalation safety study to investigate the safety of Bavituximab in up to 24 patients chronically infected with chronic hepatitis C virus (HCV) and HIV.
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In previous studies, Bavituximab when administered as monotherapy, demonstrated positive results on therapy antiviral activity of up to 1.5 log viral load reduction.
The primary endpoints of the study include safety and pharmacokinetics, and secondary endpoints will measure HCV and HIV RNA by PCR.
Peregrine Pharma president and CEO Steven King said completion of enrollment in the third Phase I HCV trial is an important milestone for Bavituximab antiviral program, and sets the stage for reporting clinical data at a medical conference in the second quarter of this year while they begin to evaluate combination treatment with the antiviral agent Ribavirin in a recently initiated study.
"Preclinical data support the potential combination of Bavituximab and Ribavirin and they look forward to seeing how this combination initially compares to standard interferon and Ribavirin treatment for 12 weeks in the Phase II study for patients infected with HCV," King said.