21 May 2013 - Biopharmaceutical company Peregrine Pharmaceuticals (NASDAQ:PPHM) said on Monday that it has formed a collaboration with the US Food and Drug Administration (FDA) to proceed with a Phase III registration trial design of its lead clinical immunotherapeutic candidate bavituximab in second-line non-small cell lung cancer (NSCLC) by year-end.

The company added that the trial design was supported by promising data from a Phase IIb trial in patients treated with bavituximab plus docetaxel. Final data from the study will be presented at the upcoming ASCO Annual Meeting on 1 June 2013.

This Phase III clinical trial will be a randomised, double-blind, placebo-controlled trial evaluating bavituximab plus docetaxel versus docetaxel alone enrolling about 600 patients at sites worldwide. The trial 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).

According to the company, bavituximab is a novel investigational immunotherapy that activates the maturation of dendritic cells and cancer-fighting (M1) macrophages leading to the development of cytotoxic T-cells that fight solid tumours. The data from three clinical trials will be presented at the ASCO Annual Meeting beginning 1 June 2013.