21 May 2013 - 21 May 2013 - US monoclonal antibodies developer Peregrine Pharmaceuticals (NASDAQ:PPHM) said on Monday it had agreed with the US FDA on the design of a Phase III registration study of its immunotherapeutic candidate bavituximab in second-line non-small cell lung cancer (NSCLC).

The study is expected to start by the end of the year.

The randomised, double-blind, placebo-controlled study will assess bavituximab plus docetaxel versus docetaxel alone. It will enroll Stage IIIB/IV non-squamous, NSCLC patients who have progressed after standard front-line treatment. The primary endpoint will be overall survival (OS).

Bavituximab is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody. PS is a highly immunosuppressive molecule found inside the membrane of healthy cells, but "flips" and becomes exposed on the outside of cells that line tumour blood vessels, causing the tumour to evade immune detection. Bavituximab targets PS and blocks this immunosuppressive signal, resulting in the maturation of dendritic cells and cancer-fighting (M1) macrophages leading to the development of cytotoxic T-cells that fight solid tumours.