Peregrine Pharmaceuticals (PPHM) announced Monday that it has entered into agreement with the U.S. Food and Drug Administration or FDA on a Phase III registration trial design of the company's lead clinical immunotherapeutic candidate bavituximab in second-line non-small cell lung cancer or NSCLC. The trial design was supported by promising data from a Phase IIb trial in patients treated with bavituximab plus docetaxel.
The company said it will present final data from the study at the upcoming ASCO Annual Meeting on Saturday, June 1, 2013.
The Phase III clinical trial will be a randomized, double-blind, placebo-controlled trial evaluating bavituximab plus docetaxel versus docetaxel alone enrolling approximately 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 of the trial will be overall survival (OS).
The company said it looks forward to finalizing the clinical protocol and initiating the global Phase III trial by year-end.
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 tumors. Bavituximab has been studied in 17 clinical trials including lung, breast, pancreatic, liver and rectal cancers.
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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.