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Antimicrobial Agents and Chemotherapy, August 2006, p. 2751-2755, Vol. 50, No. 8
0066-4804/06/$08.00+0     doi:10.1128/AAC.00096-06
Copyright © 2006, American Society for Microbiology. All Rights Reserved.

Phase II, Randomized, Double-Blind, Multicenter Study Comparing the Safety and Pharmacokinetics of Tefibazumab to Placebo for Treatment of Staphylococcus aureus Bacteremia

J. John Weems Jr.,¹ James P. Steinberg,^2, Scott Filler,³ John W. Baddley,⁴ G. Ralph Corey,⁵ Priya Sampathkumar,⁶ Lisa Winston,⁷ Joseph F. John,⁸ Christine J. Kubin,⁹ Rohit Talwani,¹⁰ Thomas Moore,^11, Joseph M. Patti,¹² Seth Hetherington,^12* Michele Texter,¹² Eric Wenzel,¹² Violet A. Kelley,¹² and Vance G. Fowler Jr.⁵

Greenville Hospital System University Medical Center, Greenville, South Carolina,¹ Emory University, Atlanta, Georgia,² Harbor-UCLA Medical Center, Torrance, California,³ UAB, Birmingham, Alabama,⁴ DUMC, Durham, North Carolina,⁵ Mayo Clinic, Rochester, Minnesota,⁶ University of California San Francisco, San Francisco, California,⁷ VAMC Charleston, Charleston, South Carolina,⁸ Columbia University, New York, New York,⁹ Palmetto Health, Columbia, South Carolina,¹⁰ Privia, The Research Centers of Via Christi, Wichita, Kansas,¹¹ Inhibitex, Alpharetta, Georgia,¹²

Received 23 January 2006/ Returned for modification 24 February 2006/ Accepted 15 May 2006

Tefibazumab (Aurexis), a humanized monoclonal antibody that binds to the surface-expressed adhesion protein clumping factor A, is under development as adjunctive therapy for serious Staphylococcus aureus infections. Sixty patients with documented S. aureus bacteremia (SAB) were randomized and received either tefibazumab at 20 mg/kg of body weight as a single infusion or a placebo in addition to an antibiotic(s). The primary objective of the study was determining safety and pharmacokinetics. An additional objective was to assess activity by a composite clinical end point (CCE). Baseline characteristics were evenly matched between groups. Seventy percent of infections were healthcare associated, and 57% had an SAB-related complication at baseline. There were no differences between the treatment groups in overall adverse clinical events or alterations in laboratory values. Two patients developed serious adverse events that were at least possibly related to tefibazumab; one hypersensitivity reaction was considered definitely related. The tefibazumab plasma half-life was 18 days. Mean plasma levels were <100 µg/ml by day 14. A CCE occurred in six patients (four placebo and two tefibazumab patients) and included five deaths (four placebo and one tefibazumab patient). Progression in the severity of sepsis occurred in four placebo and no tefibazumab patients. Tefibazumab was well tolerated, with a safety profile similar to those of other monoclonal antibodies. Additional trials are warranted to address the dosing range and efficacy of tefibazumab.

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* Corresponding author. Mailing address: Inhibitex, 9005 Westside Parkway, Alpharetta, GA 30004. Phone: (678) 746-1101. Fax: (678) 746-0615. E-mail: shetherington{at}inhibitex.com.

Present address: Emory Crawford Long Hospital, Atlanta, GA 30308.

Present address: Department of Medicine, University of Kansas School of Medicine—Wichita Campus, Wichita, KS 67214-2878.

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Antimicrobial Agents and Chemotherapy, August 2006, p. 2751-2755, Vol. 50, No. 8
0066-4804/06/$08.00+0     doi:10.1128/AAC.00096-06
Copyright © 2006, American Society for Microbiology. All Rights Reserved.

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