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New drug stimulates immune system to kill infected cells in animal model for hepatitis B infection

A novel drug developed by Gilead Sciences and tested in an animal model at the Texas Biomedical Research Institute suppresses hepatitis B virus infection by stimulating the immune system and inducing loss of infected cells.

In a study conducted at Texas Biomed’s Southwest National Primate Research Center, researchers found that the immune modulator GS-9620, which targets a receptor on immune cells, reduced both the virus levels and the number of infected liver cells in chimpanzees chronically infected with hepatitis B virus (HBV).  Chimpanzees are the only species other than humans that can be infected by HBV. Therefore, the results from this study were critical in moving the drug forward to human clinical trials which are now in progress.

The new report, co-authored by scientists from Texas Biomed and Gilead Sciences, appears in the April issue of the journal Gastroenterology (http://www.gastrojournal.org/article/S0016-5085%2813%2900169-8/abstract). Gilead researchers had previously demonstrated that the same therapy could induce a cure of hepatitis infection in woodchucks that were chronically infected with a virus similar to human HBV.

“This is an important proof-of-concept study demonstrating that the therapy stimulates the immune system to suppress the virus and eliminate infected liver cells,” said co-author Robert E. Lanford, Ph.D., of Texas Biomed. “One of the key observations was that the therapy continued to suppress virus levels for months after therapy was stopped.

The current therapy for HBV infection targets the virus and works very well at suppressing viral replication and delaying progression of liver disease, but it is a lifelong therapy that does not provide a cure.

“This GS-9620 therapy represents the first conceptually new treatment for HBV in more than a decade, and combining it with the existing antiviral therapy could be transformative in dealing with this disease,” stated Lanford.

The Gilead drug binds a receptor called Toll-Like Receptor 7 that is present in immune cells. The receptor normally recognizes invading viruses and triggers the immune system to suppress viral replication by the innate immune response and kill infected cells by the adaptive immune response, thus orchestrating both arms of the immune system.

HBV damages the liver, leading to cirrhosis and liver cancer.  Liver cancer is the fifth most common cancer worldwide and the third most common cause of cancer death. According to the United States Centers for Disease Control and Prevention (CDC), up to 1.4 million Americans are chronically infected with HBV. The World Health Organization estimates that two billion people have been infected with the hepatitis B virus, resulting in more than 240 million people with chronic infections and 620,000 deaths every year.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, Calif., Gilead has operations in North America, Europe and Asia Pacific. For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.

About Texas Biomed

Texas Biomed, formerly the Southwest Foundation for Biomedical Research, is one of the world’s leading independent biomedical research institutions dedicated to advancing health worldwide through innovative biomedical research.  Located on a 200-acre campus on the northwest side of San Antonio, Texas, the Institute partners with hundreds of researchers and institutions around the world, targeting advances in the fight against AIDS, hepatitis, malaria, parasitic infections and a host of other infectious diseases, as well as cardiovascular disease, diabetes, obesity, cancer, psychiatric disorders, and problems of pregnancy.  For more information on Texas Biomed, go to www.TxBiomed.org, or call Joe Carey, Texas Biomed’s Vice President for Public Affairs, at 210-258-9437.