Author: Wasserman, Richard L.; Lumry, William; Harris, James; Levy, Robyn; Stein, Mark; Forbes, Lisa; Cunningham-Rundles, Charlotte; Melamed, Isaac; Kobayashi, Ai Lan; Du, Wei; Kobayashi, Roger
Title: Efficacy, Safety, and Pharmacokinetics of a New 10 % Liquid Intravenous Immunoglobulin Containing High Titer Neutralizing Antibody to RSV and Other Respiratory Viruses in Subjects with Primary Immunodeficiency Disease Document date: 2016_6_20
ID: 1mmn0f98_43
Snippet: RI-002 is a safe, well-tolerated, highly effective immunoglobulin replacement for PIDD, manufactured with a unique antibody profile from a donor population tested to have elevated anti-RSV-neutralizing antibody titers. The unexpectedly low rate of infection-related outcomes suggests that the unique, anti-viral antibody profile of RI-002 may be important in the prevention of infections in PIDD subjects and raises novel questions about the role of .....
Document: RI-002 is a safe, well-tolerated, highly effective immunoglobulin replacement for PIDD, manufactured with a unique antibody profile from a donor population tested to have elevated anti-RSV-neutralizing antibody titers. The unexpectedly low rate of infection-related outcomes suggests that the unique, anti-viral antibody profile of RI-002 may be important in the prevention of infections in PIDD subjects and raises novel questions about the role of viral infections in the pathogenesis of the infectious complications of PIDD. Since it has been reported that pulmonary viral infections are often the antecedent to bacterial pulmonary infections, it is tempting to speculate that an IVIG that has high titer antibodies to viruses may also have an impact on reducing the incidence of bacterial infections.
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