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Efficacy and Safety of Treatment with an Anti-M2e Monoclonal Antibody in Experimental Human Influenza.
MedLine Citation:
PMID:  25281755     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
BACKGROUND:  The efficacy of TCN-032, a human mAb targeting a conserved epitope on M2e, was explored in experimental human influenza.
METHODS:  Healthy volunteers were inoculated with influenza A/Wisconsin/67/2005 (H3N2) and received single dose of study drug, TCN-032 or placebo 24 hours later. Subjects were monitored for symptoms, viral shedding and safety, including cytokine measurements. Oseltamivir was administered 7 days after inoculation.
RESULTS:  While the primary objective of reducing the proportion of subjects developing any Grade 2 or greater influenza symptom, or pyrexia, was not achieved, TCN-032-treated subjects showed 35% reduction (p=0.047) in median total symptom AUC (Days 1-7) and 2.2 log reduction in median viral load AUC (Days 2-7) by qPCR (p=0.095) compared to placebo subjects. TCN-032 was safe and well tolerated with no additional safety signals following administration of oseltamivir. Serum cytokine levels (IFN-γ, TNF-α, IL-8, IL-10) were similar in both groups. Genotypic and phenotypic analyses showed no difference between virus derived from subjects after TCN-032 treatment and parental strain.
CONCLUSIONS:  These data support that TCN-032 may provide immediate immunity and therapeutic benefit in influenza A infection, with no apparent emergence of resistant virus. TCN-032 was safe with no evidence of immune exacerbation based on serum cytokine expression.
Authors:
Eleanor L Ramos; Jennifer L Mitcham; Teri D Koller; Aurelio Bonavia; Dale W Usner; Ganesh Balaratnam; Paul Fredlund; Kristine M Swiderek
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2014-10-3
Journal Detail:
Title:  The Journal of infectious diseases     Volume:  -     ISSN:  1537-6613     ISO Abbreviation:  J. Infect. Dis.     Publication Date:  2014 Oct 
Date Detail:
Created Date:  2014-10-4     Completed Date:  -     Revised Date:  2014-10-5    
Medline Journal Info:
Nlm Unique ID:  0413675     Medline TA:  J Infect Dis     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
© The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.
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