The use of bacterial endotoxin in clinical research is essential to the study of the effects of inflammation on the body and as a potent stimulus to enhance immune responses in clinical trials of anti-cancer immunotherapy. The NIH Clinical Center, which holds the sole FDA master file for endotoxin preparation, provides endotoxin for research purposes at no cost to academic and pharmaceutical industry investigators worldwide.

At the recommendation of the FDA, the NIH Clinical Center and National Cancer Institute are working to develop and produce a new source of bulk endotoxin to replace the current dwindling supply and to meet current regulatory requirements for biologics.

The development and production of this important resource as an investigative tool and a novel therapeutic agent for clinical study is being supported by the private-sector. The Foundation for NIH has raised $800,000 in support of this $1.6 million project.  GlaxoSmithKline has contributed $500,000 of the funds raised to date.

Partners
AstraZeneca
GlaxoSmithKline
Johnson & Johnson
F. Hoffmann-La Roche Ltd.