ATLANTA, March 8 /PRNewswire/ -- Inhibitex, Inc., today announced that it has commenced enrollment in a Phase II clinical trial for Aurexis(R), a humanized monoclonal antibody being developed as a first-line therapy, in combination with standard of care antibiotics for serious, life threatening Staphylococcus aureus
(S. aureus) bloodstream infections in hospitalized patients. The Phase II trial will enroll up to 60-patients in a multi-center, randomized, double-blind, placebo-controlled study. Hospitalized patients will be randomized to receive standard of care antibiotic therapy combined with either Aurexis(R) or placebo. The Phase II trial is designed to evaluate the safety, pharmacokinetics and preliminary efficacy of Aurexis(R).
In 2002, there were approximately 225,000 hospital-associated S. aureus in the United States, of which approximately 50,000 were serious bloodstream infections. Studies have indicated that the mortality rate associated with methicillin resistant S. aureus or MSRA bloodstream infections is as high as 40%.
Source: Inhibitex, Inc.