Phase 2 study of bavituximab for the treatment of non-small cell lung cancer (NSCLC)

Peregrine Pharmaceuticals reported additional positive results in its Phase 2 trial evaluating bavituximab in combination with carboplatin and paclitaxel in patients with non-small cell lung cancer (NSCLC).  The primary objective of this multi-center, open-label study is to assess the overall response rate to bavituximab with carboplatin and paclitaxel. In the trial's Simon two-stage design, 21 patients with previously untreated locally advanced or metastatic NSCLC were initially enrolled, and 17 of these patients were deemed evaluable. In this initial cohort, 11 of the 17 evaluable patients achieved an objective tumor response by the time that treatment with the combination of bavituximab, carboplatin and paclitaxel was completed. These initial results exceeded the pre-specified endpoint needed to expand the trial, which then enrolled an additional 28 patients to reach the planned study total of 49 patients.  Secondary objectives of the study include measuring time to tumor progression, duration of response, overall patient survival and safety parameters.

Bavituximab is a monoclonal antibody that binds to the cellular membrane component phosphatidylserine (PS).  PS is exposed on the outside of the cells that line the blood vessels of tumors, creating a specific target for anti-cancer treatments. By binding to PS, bavituximab is believed to help mobilize the body's immune system to destroy the tumor and the tumor blood vessels.

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