FDAnews
www.fdanews.com/articles/75202-cubist-announces-end-of-dosing-in-hepatitis-b-trial

CUBIST ANNOUNCES END OF DOSING IN HEPATITIS B TRIAL

August 9, 2005

Cubist Pharmaceuticals announced that it has ended patient dosing in the second of two Phase II Hepatitis B clinical trials of HepeX-B.

Cubist plans to review data from this trial with the FDA as part of a discussion of design elements of a Phase III trial. A data-safety monitoring board recently reviewed safety data from all patients in the second Phase II trial, and no concerns were raised.

Hepatitis B is most commonly caused by the Hepatitis B virus, which, according to Datamonitor, has infected over 2 billion people around the world. Although a vaccine against HBV was introduced in 1982, globally, 350 million people are infected chronically with the disease and approximately 1 million people die each year as a result of complications from HBV infection. Current treatment regimens for chronic HBV often include use of interferon alpha or an antiviral drug.