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.


Continue Reading

For more information call (714) 508-6000 or visit www.peregrineinc.com.