"Fast Track designation further validates our belief that Aurexis has the potential to improve the clinical outcomes for patients that acquire these serious and life-threatening infections, which have documented mortality rates as high as 35 percent," commented David M. Wonnacott, PhD, vice president of regulatory affairs at Inhibitex. "We anticipate announcing the data from our ongoing Phase II trial for Aurexis in the first half of 2005. We also intend to explore the use of Aurexis in other indications, such as S. aureus infections in end-stage renal disease and cystic fibrosis patients."
Aurexis is a humanized monoclonal antibody that targets ClfA, a protein located on the surface of virtually all strains of S. aureus. Aurexis is currently being evaluated in a 60-patient Phase II clinical trial for the first-line treatment in combination with standard of care antibiotics, of serious hospital-associated S. aureus bloodstream infections. This trial is being conducted at 15 sites in the
Source: Inhibitex Inc.