Personalized site-specific immunomodulation
Inventors
Gunn, Harold David • Dhanji, Salim • Premack, Brett Anthony • Chow, Michael Tak Huai
Assignees
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Publication Number
US-8980279-B2
Publication Date
2015-03-17
Expiration Date
Abstract
The invention provides methods of treating inflammation in a specific organ or tissue of an individual. The method involves determining whether the individual has previously been infected with at least one pathogen that is pathogenic in the specific organ or tissue; and administering to the individual an anti-inflammatory composition comprising antigenic determinants, the antigenic determinants selected or formulated so that together they are specific for the at least one pathogen. The pathogen may be an endogenous or exogenous pathogen, and may further be a bacterial pathogen, a viral pathogen, a fungal pathogen, a protozoan pathogen, or a helminth pathogen.
Core Innovation
The disclosure describes personalized site-specific immunomodulation in which an individual’s prior infection or exposure to a pathogen known to be pathogenic in a target organ or tissue is assessed, and an anti-inflammatory or therapeutic composition is administered. The administered composition contains pathogen-specific antigenic determinants intended to modulate an immune response in a site-specific manner associated with the target organ or tissue.
The composition includes endogenous or exogenous pathogens spanning bacterial, viral, fungal, protozoan, and helminth pathogen types, and may comprise killed whole pathogens, attenuated pathogens, or antigenic components. The disclosed administration is performed in a non-enteric manner, including intradermal and subcutaneous administration, to elicit a localized immune response.
For Crohn’s disease, the invention administers an antigenic formulation comprising whole killed Escherichia coli cells in successive doses, derived from an E. coli strain that is pathogenic in colon. The administration is intradermal or subcutaneous for a therapeutically effective reduction or elimination of Crohn’s disease symptoms.
Claims Coverage
The claim coverage centers on a Crohn’s disease treatment method using whole killed colon-pathogenic E. coli administered intradermally or subcutaneously in successive doses. The excerpt also identifies dependent claim features that further define dosage duration, dosing frequency, localized inflammatory response, and the source of the E. coli strain.
Crohn’s disease treatment with intradermal or subcutaneous whole killed colon-pathogenic E. coli
Administering to a human patient having Crohn’s disease and exhibiting symptoms an antigenic formulation comprising whole killed Escherichia coli cells in successive doses intradermally or subcutaneously, wherein the whole killed E. coli cells are cells of an E. coli strain that is pathogenic in colon.
Successive dosing over 4 days to 1 week with at least one-hour dose interval
Administering two or more doses over a period from 4 days to 1 week, with a dosage interval of at least one hour, and having the amount of the antigenic formulation and duration of administering therapeutically effective to reduce or eliminate the symptoms of Crohn’s disease in the human patient, wherein the dosage duration is at least one week.
Minimum dosage duration of at least two weeks
Carrying out the method with a dosage duration of at least two weeks.
Subcutaneous daily or every-other-day dosing schedule
Administering the antigenic formulation subcutaneously either daily or every other day.
Visible localized inflammatory immune response at the administration site
Administering an antigenic formulation such that for each dose there is a visible localized inflammatory immune response in an administration site.
Visible localized inflammation within 1 to 48 hours
Administering the antigenic formulation such that visible localized inflammation at the administration site occurs within 1 to 48 hours after administration.
Whole killed E. coli from a patient-collected colonic infection strain
Administering whole killed E. coli cells taken from an E. coli strain collected from a patient with an E. coli colonic infection.
The claim set is directed to Crohn’s disease treatment using intradermal or subcutaneous successive dosing of whole killed E. coli from a colon-pathogenic strain, with therapeutically effective dosing over specified time windows. The dependent features further narrow the regimen by requiring longer dosage duration, specifying subcutaneous schedule options, and defining a visible localized inflammatory immune response at the administration site within a defined time window, including an E. coli strain source tied to a patient-collected colonic infection isolate.
Stated Advantages
Reduce or eliminate symptoms of Crohn’s disease in the human patient.
Documented Applications
Treating a human patient having Crohn’s disease by administering an antigenic formulation comprising whole killed Escherichia coli cells as successive intradermal or subcutaneous doses.
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