Peregrine Pharmaceuticals Doses First Patient in Clinical Trial of Bavituximab in HCV Patients Co-Infected With HIV
New Trial in Important Patient Subgroup Will Assess Safety and Anti-Viral Activity
Peregrine Pharmaceuticals, Inc. announced that the first patient has been dosed in a clinical trial designed to evaluate the safety and pharmacokinetics of bavituximab in patients co-infected with HCV and the human immunodeficiency virus (HIV). The multi-center trial is being conducted initially at Saint Michael's Medical Center in Newark, NJ under the guidance of Dr. Stephen Smith, director of the Peter Ho Memorial Clinic, the largest HIV/AIDS treatment facility in the state.
This open-label, dose escalation study will be conducted in approximately 24 patients chronically infected with HCV and HIV. Patient cohorts will receive ascending dose levels of bavituximab weekly for up to eight weeks. HCV and HIV viral titers and other biomarkers will be evaluated, although they are not formal study endpoints.
Bavituximab is a monoclonal antibody in a new class of anti-phosphotidylserine (PS) immunotherapeutics that targets and binds to cellular components that are normally not present on the outside of cells, but which become exposed on certain virally infected cells and on the surface of enveloped viruses, including both HCV and HIV. Bavituximab helps stimulate the body's immune defenses to destroy both the virus particles and the infected cells. Since bavituximab's PS target comes from the host and not the virus, bavituximab may be less susceptible to the development of anti-viral resistance. Peregrine has completed two bavituximab Phase l monotherapy clinical trials in patients with chronic HCV infection. In these trials, the drug appeared safe and well tolerated with encouraging signs of anti-viral activity.
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