Peregrine Pharmaceuticals announced interim results from its randomized, double-blind, placebo-controlled Phase 2b trial of bavituximab in patients with refractory non-small cell lung cancer (NSCLC).

The trial enrolled 121 patients (117 evaluable per the study protocol) with second-line non-squamous NSCLC following one prior chemotherapy regimen. Patients were equally randomized to 1 of the 3 treatment arms: docetaxel 75mg/m2 (Taxotere; Sanofi Aventis) plus placebo, 1mg/kg bavituximab, or 3mg/kg bavituximab until disease progression.

The interim data showed a statistically significant improvement in overall survival and a doubling of median overall survival (OS) in the bavituximab-containing arms compared to the control arm (12.1 months vs. 5.6 months; Hazard Ratio 0.524, P=0.0154).

Bavituximab is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody. PS is a highly immunosuppressive molecule usually located inside the membrane of healthy cells, but “flips” and becomes exposed on the outside of cells that line tumor blood vessels, creating a specific target for anti-cancer treatments. PS-targeting antibodies target and bind to PS and block this immunosuppressive signal, thereby enabling the immune system to recognize and fight the tumor.

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