A Phase III, Randomized, Double-blind, Multi-center Clinical Trial Comparing the Safety and Efficacy of Veronate® Versus Placebo for the Prevention of Nosocomial Staphylococcal Sepsis in Premature Infants (Birth Weight 500 - 1250 g)

The purpose of this study is to show whether Veronate, a donor-selected staphylococcal human immune globulin intravenous (IGIV), can prevent an infection in the blood caused by staphylococcal bacteria in premature babies weighing between 500 and 1250 grams at birth.
Babies are enrolled between Day of Life 3 and 5. Babies are randomized to either Veronate or placebo (50-50 chance of either). Babies can receive up to 4 doses of the study drug on Study Days 1, 3, 8 and 15 and are followed until Study Day 70 or discharge from the hospital.

Start Date01 May 2004

Sponsor / Collaborator

Bristol Myers Squibb Co.

100 Clinical Results associated with INHA-21

100 Translational Medicine associated with INHA-21

100 Patents (Medical) associated with INHA-21

Literatures (Medical) associated with INHA-21

01 Sep 2007·The Journal of PediatricsQ2 · MEDICINE

Clinical Trial of Safety and Efficacy of IHN-A21 for the Prevention of Nosocomial Staphylococcal Bloodstream Infection in Premature Infants

Q2 · MEDICINE

Article

Author: Fabien Eyal ; Joe Patti ; Karen Kesler ; Mark Polak ; Robert Schelonka ; Whit Walker ; Dietra Millard ; Elizabeth Jung ; Destrey Roberson ; Mitchell DeJonge ; Amy Morris ; David Burchfield ; Barry Bloom ; Maria Duenas ; Seth Hetherington ; Barry Kapik

OBJECTIVETo determine if INH-A21, an intravenous immune globulin (IGIV) derived from donors with high titers of antibody to surface adhesins of Staphylococcus epidermidis and S. aureus prevents late-onset sepsis (LOS) in very low birth weight (VLBW) infants.STUDY DESIGNIn this double-blind, placebo-controlled study, infants with birth weights 500 to 1250 g were randomized to receive up to four doses of INH-A21 (Veronate) or placebo. The primary objective was to determine the safety and efficacy of INH-A21 versus placebo for prevention of S. aureus LOS in VLBW infants.RESULTSA total of 1983 infants from 95 neonatal intensive care units were randomized, and received at least one dose of study drug. S. aureus LOS developed in 50 of 989 (5%) and 60 of 994 (6%) infants who received placebo or INH-A21, respectively (P = .34). No differences were found in the frequencies of LOS caused by coagulase-negative staphylococci (CoNS), Candida spp, or overall mortality. No adverse events were statistically significantly associated with INH-A21 infusions compared with placebo.CONCLUSIONINH-A21 failed to reduce the incidence of staphylococcal LOS or candidemia in premature infants.

01 Jan 2007·Archives de PédiatrieQ4 · MEDICINE

Antibody for the prevention of neonatal noscocomial staphylococcal infection: a review of the literature

Q4 · MEDICINE

Review

Author: Weisman, L E

Staphylococci, especially coagulase negative staphylococci (CONS), are responsible for over 75 % of late-onset infections in very low birth weight infants. These infections cause increased length of hospital stay, need for antibiotics, and cost of medical care. Several drug companies have developed and evaluated hyperimmune polyclonal and monoclonal antibodies for the prevention of neonatal staphylococcal infection including 1) Altastaph by North American Biologics Inc., 2) Veronate by Inhibitex Inc., and 3) Pagibaximab by Biosynexus Inc, and Glaxo Smith Kline Inc. We will review the development and status of these potential products. Altastaph is a S. aureus serotype 5 and 8 vaccine induced hyperimmune polyclonal antibody whose development has been placed on hold due to its failure to demonstrate any trend toward efficacy in a recently completed Phase II study. Veronate is a polyclonal antibody obtained by plasmapheresis from donors with high titers of MSCRAMM (microbial surface components recognizing adhesion matrix molecules) activity against CONS whose development has been placed on hold due to its failure to demonstrate effectiveness in a recently completed Phase III study. Pagibaximab is a humanized mouse chimeric monoclonal antibody (previously known as BSYX-A110) directed against lipoteichoic acid (LTA), a major cell wall component of gram-positive bacteria, that has recently completed a Phase II study suggesting efficacy and is being developed further for clinical investigation.

01 Jun 2006·Expert Opinion on Investigational DrugsQ2 · MEDICINE

INH-A21: a donor-selected Staphylococcal human immune globulin for the prevention of late-onset neonatal Staphylococcal infection

Q2 · MEDICINE

Article

Author: Bloom, Barry T

INH-A21 is an experimental human immune globulin for intravenous infusion (IGIV) derived from donors specifically selected for elevated levels of antibodies against the Staphylococcal fibrinogen-binding proteins, serine aspartate dipeptide repeat G and clumping factor A. Phase II results demonstrated that infusions of INH-A21 were well tolerated and there were no trends for increasing adverse events, or the common morbidities associated with prematurity. Enrollment has been completed in (but no results have been released from) a Phase III human trial testing INH-A21 as a prophylactic agent against staphylococcal infection in very low birth weight infants (500-1250 g).

100 Deals associated with INHA-21

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Candidemia	NDA/BLA	United States	Bristol Myers Squibb Co.	01 May 2004
Candidemia	NDA/BLA	Canada	Bristol Myers Squibb Co.	01 May 2004
Cross Infection	NDA/BLA	United States	-	-
Cross Infection	NDA/BLA	United States	-	-
Neonatal infections	NDA/BLA	United States	-	-
Staphylococcal Infections	NDA/BLA	United States	-	-
Staphylococcal Infections	NDA/BLA	United States	-	-

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00113191 (Pubmed \| J Pediatr)	Not Applicable	Sepsis	1,983	INH-A21	bjcglarwde(mspawxcdio) = mzhbrdewsm ynezjmnvfs (sqlnoffitt )	Negative	01 Sep 2007
				Placebo	bjcglarwde(mspawxcdio) = glqehfuuys ynezjmnvfs (sqlnoffitt )

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