NABI REPORTS ENCOURAGING PHASE I/II ALTASTAPH RESULTS IN ADULTS

Nabi Biopharmaceuticals has announced encouraging results from its U.S. Phase I/II clinical trial using Altastaph [Staphylococcus aureus Immune Globulin Intravenous (Human)] to treat adult in-hospital patients with persistent Staphylococcus aureus (S. aureus) bloodstream infections (bacteremia).

In this study there was a 36 percent reduction in median time from administration of the study drug to hospital discharge in the Altastaph-treated patients as compared to the placebo-treated patients (nine days in the Altastaph group versus 14 days in the placebo group). This substantial reduction in the length of hospital stay for the Altastaph-treated group indicates that S. aureus antibodies provided by Altastaph could be associated with considerable medical benefit in the treatment of persistent S. aureus infections.

The study was a double-blinded, placebo-controlled, randomized trial in 40 patients with persistent S. aureus blood stream infections designed to evaluate the safety of Altastaph and to measure S. aureus specific antibody levels. Patients were randomly allocated to receive two intravenous doses of Altastaph or saline placebo in combination with standard-of-care treatment, which included treatment with antibiotics. The results of the study demonstrated that Altastaph was well tolerated and no drug-related, serious adverse events were reported. Patients were able to maintain antibody titers at or above levels previously demonstrated to be protective against S. aureus infections in patients with end-stage renal disease. In addition, as outlined above, Altastaph treatment was associated with a substantial reduction in time to hospital discharge.