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ROCKVILLE, Md. -- Nabi Biopharmaceuticals announced today, for the first time, data showing that patients treated with Altastaph [Staphylococcus aureus Immune Globulin Intravenous (Human)] had a shorter duration of bacteremia and fever vs. the placebo group. As previously reported, the treated group also left the hospital sooner. Altastaph is Nabi Biopharmaceuticals' investigational human antibody-based product in development to treat adult in-hospital patients with persistent S. aureus bacteremia.
Mark E. Rupp, MD, from the University of Nebraska Medical Center, presented the full Phase I/II results at the 43rd Infectious Diseases Society of America (IDSA) annual meeting in San Francisco.
"Infection due to Staphylococcus aureus is a significant medical problem that is, unfortunately, increasingly observed," stated Rupp. "The growing prevalence of antibiotic-resistance in staphylococci reinforces the need for new antibiotics and innovative measures, such as Altastaph. This Phase I/II study showed that Altastaph was generally well tolerated, similar to other IVIG products. Patients treated with Altastaph had high levels of antibodies, which result in the killing of bacteria. Additional studies are warranted to further define the efficacy of Altastaph, a promising therapeutic agent."
Rupp's presentation focused on the results of the Altastaph U.S. Phase I/II clinical trial in treating adult in-hospital patients with persistent S. aureus 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 vs. 14 days in the placebo group). This
substantial reduction in the length of hospital stays for the Altastaph-treated group indicates that S. aureus antibodies provided by Altastaph could be associated with considerable medical as well as health economic benefit in the treatment of persistent S. aureus infections.
The study results also showed a shorter duration of bacteremia (one day in the Altastaph group vs. two days in the placebo group) and fever (two days in the Altastaph group vs. seven days in the placebo group).
Source: Nabi Biopharmaceuticals