"Our research has demonstrated that sorafenib increases the exposure of the highly immunosuppressive molecule phosphatidylserine (PS) on tumor vasculature, providing more of a specific target for bavituximab," said Adam C. Yopp, M.D., lead investigator of this trial and assistant professor of surgery at the University of Texas Southwestern Medical Center. "We are eager to determine if combining the growth-blocking mechanisms of sorafenib with the vascular-targeting and immune-reactivation mechanisms of bavituximab offers additive anti-tumor effects for patients with HCC."
Currently, Peregrine's bavituximab is being evaluated in combination with chemotherapy in multiple Phase II trials in non-small cell lung cancer and advanced breast cancer, as well as a Phase Ib trial for hepatitis C virus (HCV) and HIV coinfection.
"In prior studies, bavituximab has demonstrated broad therapeutic potential in multiple oncology indications," said Marvin R. Garovoy, M.D., head of clinical science at Peregrine Pharmaceuticals. "Our IST program is designed to provide valuable clinical data on bavituximab's potential use in different therapeutic combinations and indications. We also expect to further clarify details of bavituximab's multiple mechanisms of action, and to identify specific biomarkers that could ultimately help to measure and predict bavituximab's potential anti-tumor and immunostimulatory effects. We look forward to collaborating with Dr. Yopp and his team, as well as other investigators who have applied for our program."