The open-label, multicenter trial is being conducted in the United States and will evaluate Peregrine's bavituximab, a phosphatidylserine (PS)-targeting monoclonal antibody with broad therapeutic potential, in combination with the chemotherapeutic agent gemcitabine versus gemcitabine monotherapy.
"There is a critical need for new therapeutic options for patients diagnosed with metastatic pancreatic cancer, as median overall survival is limited to 6 months with single-agent chemotherapy," said Shuchi (Susan) Pandya, M.D., a principal investigator of this trial and clinical faculty of Hematology and Oncology at the Beth Israel Deaconess Medical Center, a major teaching hospital of Harvard Medical School in Boston. "Prior published data show combining the PS-targeting antibody bavituximab with gemcitabine, a chemotherapy that has been shown to increase PS exposure on tumor blood vessels, enhances anti-tumor effects and controls metastatic growth without added toxicity over gemcitabine alone in animal models of pancreatic cancer. As investigational therapies have yet to prolong survival without causing significant toxicities, we are eager to evaluate this investigational combination therapy in a randomized clinical trial setting."
Currently, Peregrine's bavituximab is being evaluated in combination with chemotherapy in two Phase IIb trials in non-small cell lung cancer, a Phase I/II trial in combination with sorafenib in advanced hepatocellular carcinoma (HCC), as well as a Phase Ib trial for hepatitis C virus (HCV).
"We were inspired to conduct this study based on the encouraging and consistent signs of bavituximab's anti-tumor activity across multiple oncology indications as well as the promising preclinical data supporting the potential of bavituximab in combination with gemcitabine in advanced pancreatic cancer models," said Steven W. King, president and chief executive officer of Peregrine. "With the initiation of our third randomized Phase II oncology trial for bavituximab, we are setting the stage for multiple clinical data reports over the coming year."