Press Release
XBiotech Completes Enrollment in Global Phase I/II Study for its True Human™ Antibody Treatment for Serious Staphylococcus aureus Infections
“We are pleased to announce enrollment completion in this study,” said
Patients enrolled in the Phase II portion of the study were randomized to receive the highest dose of 514G3, as determined by the Phase I portion of the study, plus standard of care antibiotics vs. placebo plus antibiotics. Patients were treated in hospital settings at sites in
About 514G3
514G3 was developed from a healthy human donor with natural antibodies effective at neutralizing MRSA and non-MRSA forms of S. aureus. 514G3 knocks out the principle immune evasion mechanism of the bacteria, allowing white blood cells to detect and destroy the bacteria. 514G3 has potential to treat all strains of MRSA and can be used without consideration for strain-specific resistance to various antibiotics. As a True Human monoclonal antibody, 514G3 is expected to be well tolerated without the side effects or risks of antibiotics, including the lack of risk of antibiotic resistance.
About Staphylococcus aureus
Staphylococcus aureus (S. aureus) is a leading cause of bacteremia and is associated with higher morbidity compared with other pathogens. S. aureus bloodstream infections are among the most common but also most difficult to treat1. The incidence of S. aureus, specifically bacteremia caused by methicillin-resistant S. aureus (MRSA) strains, has dramatically increased in recent years in the U.S. and parts of
About True Human™ Therapeutic Antibodies
Unlike previous generations of antibody therapies, XBiotech’s True Human™ antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.
About XBiotech
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This press release contains forward-looking statements, including declarations regarding management's beliefs and expectations that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "would," "could," "expects," "plans," "contemplate," "anticipates," "believes," "estimates," "predicts," "projects," "intend" or "continue" or the negative of such terms or other comparable terminology, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to inherent risks and uncertainties in predicting future results and conditions that could cause the actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties are subject to the disclosures set forth in the "Risk Factors" section of certain of our
1 Wisplinghoff H, Bischoff T, Tallent SM, Seifert H, Wenzel RP, Edmond MB. Nosocomial bloodstream infections in US hospitals: analysis of 24,179 cases from a prospective nationwide surveillance study. Clin Infect Dis 2004; 39:309–17.
2 Steinberg JP, Clark CC, Hackman BO. Nosocomial and community acquired Staphylococcus aureus bacteremias from 1980 to 1993: impact of intravascular devices and methicillin resistance. Clin Infect Dis 1996; 23:255–9.
3 EARSS management team. European Antimicrobial Resistance Surveillance System annual report 2006. Bilthoven,
4 Shorr AF, Lodise T. Burden of methicillin-resistant Staphylococcus aureus on healthcare cost and resource utilization. ISMR Update 2006; 1:4–11.
ContactAshley Otero aotero@xbiotech.com 512.386.2930