Drug evaluation: Tefibazumab - A monoclonal anatibody against staphylococcal infection

Current Opinion in Molecular Therapeutics

Volumn 8, Issue 5, 2006, Pages 455-460

  John Jr , Joseph F ^a  

^a MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AUREXIS; BACTERIAL PROTEIN; EPITOPE; FIBRIN; METICILLIN; MONOCLONAL ANTIBODY; PLACEBO; TEFIBAZUMAB; UNCLASSIFIED DRUG; VANCOMYCIN;

AGGRESSION; ANTIBACTERIAL ACTIVITY; AREA UNDER THE CURVE; BACTEREMIA; BACTERIAL ENDOCARDITIS; BACTERIAL STRAIN; CLINICAL TRIAL; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG HALF LIFE; DRUG HYPERSENSITIVITY; DRUG SPECIFICITY; DRUG TOLERABILITY; DRUG TRANSPORT; HEADACHE; HUMAN; IN VIVO STUDY; INJECTION SITE INFLAMMATION; KIDNEY FAILURE; LETHARGY; LICENCE; METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS; NEUTROPENIA; NONHUMAN; PATENT; PROTEIN BINDING; PROTEIN EXPRESSION; RABBIT; REVIEW; SKIN MANIFESTATION; STAPHYLOCOCCUS; STAPHYLOCOCCUS AUREUS; STAPHYLOCOCCUS INFECTION; TREATMENT OUTCOME;

ADHESINS, BACTERIAL; ANTIBODIES, MONOCLONAL; BACTERIAL PROTEINS; CLINICAL TRIALS, PHASE II; CLINICAL TRIALS, PHASE II AS TOPIC; COAGULASE; HUMANS; RANDOMIZED CONTROLLED TRIALS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; STAPHYLOCOCCAL INFECTIONS; STAPHYLOCOCCUS AUREUS;

STAPHYLOCOCCUS AUREUS;

EID: 33750019510     PISSN: 14648431     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (31)

1. 515968 Characterization of a protective monoclonal antibody recognizing Staphytococcus aureus MSCRAMM protein clumping factor A. Hall AE, Domanski PJ, Patel PR, Vemachio JH, Syribeys PJ, Gorovits EL, Johnson MA, Ross JM, Hutchins JT, Patti JM INFECT IMMUN 2003 71 12 6864-6870
2. 528880 Anti-clumping factor A immunoglobulin reduces the duration of methicillin-resistant Staphylococcus aureus bacteremia in an experimental model of infective endocarditis. Vernachio J, Bayer AS, Le Thuan CYL, Prater B, Schneider A, Ames B, Syribeys P, Robbins J, Patti JM ANTIMICROB AGENTS CHEMOTHER 2003 4711 3400-3406
3. 559885 FDA grants Inhibitex Fast Track designation for Aurexis. Inhibitex Inc PRESS RELEASE 2004 September 21
4. 568662 Monoclonal antibodies as 'first-line' therapy for severe S aureus infections. Patti JM ICAAC 2004 44 Abs 1287
5. 568887 A dose escalation phase I study to evaluate safety and pharmacokinetics (PK) of tefibazumab in healthy volunteers. Hetherington S, Patti J, Wenzel E, Bennett B, Reilley S, Reynolds L ICAAC 2004 44 Abs A-30
6. 591092 Open-label, dose escalation study of the safety and pharmacokinetic profile of tefibazumab in healthy volunteers. Reilley S, Wenzel E, Reynolds L, Bennett B, Patti JM, Hetherington S ANTIMICROB AGENTS CHEMOTHER 2005 49 3 959-962
7. 591093 A humanized monoclonal antibody targeting Staphylococcus aureus. Patti JM VACCINE 2004 22 Suppl 1 S39-S43
8. 591094 Evaluation of the biological activity of aurexis, a humanized mAb for the first-line treatment of severe S aureus infections in combination vith antibiotics. Hutchins JT, Zhang L, Patti JM HUM ANTIBODIES 2004 13 1-2 18
9. 591268 Inhibitex's net loss remains stable but revenue drops in 2004. Inhibitex Inc PRESS RELEASE 2005 March 23
10. 600166 Inhibitex reports favorable results from Aurexis phase II trial for the treatment of staph bloodstream infections. Inhibitex Inc PRESS RELEASE 2005 May 09
11. 640097 A dose escalation phase I study to evaluate the safety and pharmacokinetic (PK) profile of Aurexis in subjects with end-stage renal disease (ESRD) requiring hemodialysis. Hetherington S, Texter M, Wenzel E, Patti J, Reynolds L ICAAC 2005 46 Abs A-1 5
12. 656408 Lilly and Biosite to collaborate on clinical trial using tailored Xigris therapy. Eli Lilly & Co, Biosite Inc PRESS RELEASE 2006 March 20
13. 657781 Product candidates: Aurexis. COMPANY WORLD WIDE WEB SITE 2006 www.inhibitex.com
14. 665846 Inhibitex Inc reports first quarter 2006 financial results. Inhibitex Inc PRESS RELEASE 2008 May 05
15. 672485 Characterization of a humanized monoclonal antibody recognizing clumping factor A expressed by Staphylococcus aureus. Domanski PJ, Patel PR, Bayer AS, Zhang L, Hall AE, Syribeys PJ, Gorovits EL, Bryant D, Vernachio JH, Patti JM INFECT IMMUN 2005 73 8 5229-5232
16. 676375 Inhibitex to buy drug candidates to bolster late-stage pipeline. Inhibitex Inc PRESS RELEASE 2006 June 29
17. 677605 Emergence of community-acquired methicillin-resistant Staphylococcus aureus USA 300 clone as the predominant cause of skin and soft-tissue infection. King MD, Humphrey BJ, Wang YF, Kourbatova EV, Ray SM, Blumberg HM ANN INTERN MED 2006 144 5 309-317
18. 677606 Clumping factor A of Staphylococcus aureus inhibits phagocytosis by human polymorphonuclear leucocytes. Higgins J, Lounghman A, van Kassel KPM, van Strijp JAG, Foster TJ FEMS MICROBIOL LETT 2006 258 2 290-296
19. 677620 The burden of Staphylococcus aureus infections on hospitals in the United States: An analysis of the 200 and 2001 Nationwide Inpatient Sample Database. Noskin GA, Rubin RJ, Schentag JJ, Kluytmans J, Hedblom EC, Smulders M, Lapetina E, Gemmen E ARCH INTERN MED 2005 165 15 1756-1761
20. 677622 Clinical Identifiers of complicated Staphylococcus aureus bacteremia. Fowler VG Jr, Olsen MK, Corey GR, Woods CW, Cabell CH, Reller LB, Cheng AC, Dudley T, Oddone EZ ARCH INTERN MED 2003 163 17 2066-2072
21. 677631 Roles of 34 virulence genes in the evolution of hospital- and community-associated strains of methicillin-resistant Staphylococcus aureus. Diep BA, Carleton HA, Chang RF, Sensabaugh GF, Perdreau-Remington F J INFECT DIS 2006 193 11 1495-1503
22. 678085 Staphylococcal Infections: Emerging clinical syndromes. John JF, In: Staphylococcus Aureus: Molecular and Clinical Aspects Ala'Aldeen D, Hiramatsu K (Eds), Horwood Publishers, Chichester, UK 2002 1-30
23. 678086 Antimicrobial resistance and therapy of Staphylococcus aureus Infections. Chambers HF, In: Staphylococcus Aureus: Molecular and Clinical Aspects Ala'Aldeen D, Hiramatsu K (Eds), Horwood Publishers, Chichester, UK 2002 237-267
24. 678216 Clumping factor A mediates binding of Staphylococcus aureus to human platelets. Siboo IR, Cheung AL, Bayer AS, Sullam PM INFECT IMMUN 2001 69 5 3120-3127
25. 678457 Secrets of success of a human pathogen: Molecular evolution of pandemic clones of methicillin-resistant Staphylococcus aureus. Oliveira DC, Tomasz A, de Lencastre H LANCET INFECT DIS 2002 2 3 180-189
26. 678469 A phase II randomized, double-blind, multi-center study comparing safety and pharmacokinetics of tefibazumab to placebo for the treatment of Staphylococcus aureus bacteremia. Weems JJ, Steinberg JP, Filler S, Baddley J, Heterington S, Fowler V ICAAC 2005 45 Abs K-425
27. 682323 The epidemiology of Staphylococcus infections. Tenover FC, Gorwitz RJ, In: Gram-Positive Pathogens Fischetti VA, Nocik RP, Ferretti JJ, Portnoy DA, Rood JI (Eds), ASM Press, Washington DC, USA 2006 2 526-534
28. 682326 Staphylococcal pathogenesis and pathogenicity factors: Genetics and regulation. Novick RP, In: Gram-Positive Pathogens Fischetti VA, Nocik RP, Ferretti JJ, Portnoy DA, Rood JI (Eds), ASM Press, Washington DC, USA 2006 2 496-516
29. 682346 Clinical investigator's brochure. Inhibitex Inc COMPANY PUBLICATION 2005
30. 685171 Phase II, randomized, double-blind, multicenter study comparing the safety and pharmacokinetics of tefibazumab to placebo for treatment of Staphylococcus aureus bacteremia. Weems JJ Jr, Steinberg JP, Filler S, Baddley JW, Corey GR, Sampathkumar P, Winston L, John JF, Kubin CJ, Talwani R, Moore T et al ANTIMICROB AGENTS CHEMOTHER 2006 50 8 2751-2755
31. 686791 Immune evasion by staphylococci. Foster T NAT REV MICROBIOL 2005 3 12 948-958