Site-Specific Immunomodulator: A Novel Treatment for Crohn's Disease

We investigated the mechanism of action, safety, and efficacy of the Site-Specific Immunomodulator (SSI) QBECO, a novel immunotherapy for Crohn's disease (CD). Using human monocytic THP-1 cells, we demonstrate that SSI QBECO (derived from the common colon bacteria E. coli) activates macrophages...

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Main Authors:	Bressler, Brian, Bethel, Kevin P., Kleef, Ralf, Reynolds, Sophie L., Sutcliffe, Simon, Mullins, David W., Gunn, Hal
Format:	Online
Language:	English
Published:	Hindawi Publishing Corporation 2015
Online Access:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4443884/

id	pubmed-4443884
recordtype	oai_dc
spelling	pubmed-44438842015-06-10 Site-Specific Immunomodulator: A Novel Treatment for Crohn's Disease Bressler, Brian Bethel, Kevin P. Kleef, Ralf Reynolds, Sophie L. Sutcliffe, Simon Mullins, David W. Gunn, Hal Clinical Study We investigated the mechanism of action, safety, and efficacy of the Site-Specific Immunomodulator (SSI) QBECO, a novel immunotherapy for Crohn's disease (CD). Using human monocytic THP-1 cells, we demonstrate that SSI QBECO (derived from the common colon bacteria E. coli) activates macrophages to an M1 phenotype (associated with enhanced capacity to eliminate bacteria and activate innate immune responses). We assessed SSI QBECO in a compassionate use protocol of ten adult patients with active CD. Patients with moderate to severe clinical symptoms receiving conventional CD treatments and/or complementary therapies were included, except patients receiving anti-TNF medications. SSI QBECO was self-administered subcutaneously every second day, for a minimum of 2.5 months and a maximum of 11 months. All 10 patients reported improvement of symptoms while on the SSI QBECO treatment. Seven patients reported full resolution of clinical symptoms during a course of SSI QBECO of at least three months. Three patients have experienced ongoing sustained clinical remission after discontinuing all medications, including SSI treatment. The longest case of clinical remission is still ongoing (>4 years). No serious severe adverse clinical events were reported. Collectively, we conclude that treatment with the immunoactive SSI QBECO was well tolerated and effective for treatment of Crohn's disease in this case series. Hindawi Publishing Corporation 2015 2015-05-12 /pmc/articles/PMC4443884/ /pubmed/26064087 http://dx.doi.org/10.1155/2015/231243 Text en Copyright © 2015 Brian Bressler et al. https://creativecommons.org/licenses/by/3.0/ This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
repository_type	Open Access Journal
institution_category	Foreign Institution
institution	US National Center for Biotechnology Information
building	NCBI PubMed
collection	Online Access
language	English
format	Online
author	Bressler, Brian Bethel, Kevin P. Kleef, Ralf Reynolds, Sophie L. Sutcliffe, Simon Mullins, David W. Gunn, Hal
spellingShingle	Bressler, Brian Bethel, Kevin P. Kleef, Ralf Reynolds, Sophie L. Sutcliffe, Simon Mullins, David W. Gunn, Hal Site-Specific Immunomodulator: A Novel Treatment for Crohn's Disease
author_facet	Bressler, Brian Bethel, Kevin P. Kleef, Ralf Reynolds, Sophie L. Sutcliffe, Simon Mullins, David W. Gunn, Hal
author_sort	Bressler, Brian
title	Site-Specific Immunomodulator: A Novel Treatment for Crohn's Disease
title_short	Site-Specific Immunomodulator: A Novel Treatment for Crohn's Disease
title_full	Site-Specific Immunomodulator: A Novel Treatment for Crohn's Disease
title_fullStr	Site-Specific Immunomodulator: A Novel Treatment for Crohn's Disease
title_full_unstemmed	Site-Specific Immunomodulator: A Novel Treatment for Crohn's Disease
title_sort	site-specific immunomodulator: a novel treatment for crohn's disease
description	We investigated the mechanism of action, safety, and efficacy of the Site-Specific Immunomodulator (SSI) QBECO, a novel immunotherapy for Crohn's disease (CD). Using human monocytic THP-1 cells, we demonstrate that SSI QBECO (derived from the common colon bacteria E. coli) activates macrophages to an M1 phenotype (associated with enhanced capacity to eliminate bacteria and activate innate immune responses). We assessed SSI QBECO in a compassionate use protocol of ten adult patients with active CD. Patients with moderate to severe clinical symptoms receiving conventional CD treatments and/or complementary therapies were included, except patients receiving anti-TNF medications. SSI QBECO was self-administered subcutaneously every second day, for a minimum of 2.5 months and a maximum of 11 months. All 10 patients reported improvement of symptoms while on the SSI QBECO treatment. Seven patients reported full resolution of clinical symptoms during a course of SSI QBECO of at least three months. Three patients have experienced ongoing sustained clinical remission after discontinuing all medications, including SSI treatment. The longest case of clinical remission is still ongoing (>4 years). No serious severe adverse clinical events were reported. Collectively, we conclude that treatment with the immunoactive SSI QBECO was well tolerated and effective for treatment of Crohn's disease in this case series.
publisher	Hindawi Publishing Corporation
publishDate	2015
url	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4443884/
_version_	1613227635590037504

Site-Specific Immunomodulator: A Novel Treatment for Crohn's Disease

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