ATLANTA -- Inhibitex, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Aurexis, its humanized monoclonal antibody, Fast Track designation. Aurexis is currently being evaluated in a Phase II clinical trial for the first-line treatment of serious hospital-associated Staphylococcus aureus (S. aureus) bloodstream infections. Fast Track designation is provided by the FDA to potentially facilitate the development and expeditious review or approval of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
"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 U.S. The objectives of the trial are to further study the safety and pharmacokinetics of Aurexis in its intended patient population and to assess initial biological activity as measured by reductions in mortality, relapse rates and secondary sites of infections attributable to S. aureus bloodstream infections.
Source: Inhibitex Inc.