US2019219594A1PendingUtilityA1

Predictive biomarkers of clinical response to anti-lps immunoglobulin treatment

Assignee: UNIV WUERZBURG J MAXIMILIANSPriority: Apr 17, 2015Filed: Feb 22, 2019Published: Jul 18, 2019
Est. expiryApr 17, 2035(~8.7 yrs left)· nominal 20-yr term from priority
A61P 9/10A61P 37/02A61P 25/04A61P 29/00A61P 25/06A61P 19/04A61P 1/02A61P 1/04A61P 17/02A61P 17/00A61P 19/02A61P 1/00A61P 13/10C07K 2317/23G01N 2333/54G01N 2333/475G01N 2333/70596G01N 2333/5421G01N 33/6866C12Q 1/6883G01N 33/6869G01N 33/56911G01N 2333/521G01N 2333/5412G01N 2333/56C07K 16/1203A61K 39/39583A61K 2039/505G01N 33/6863G01N 2800/26G01N 2800/125G01N 33/92C07K 16/44C07K 2317/11A61K 39/40G01N 2400/50G01N 2333/4756C12Q 2600/158C12Q 2600/106C12Q 1/6876G01N 2333/705G01N 2800/52G01N 2333/916G01N 2333/5428
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Claims

Abstract

The present invention relates to the biomarkers for predicting the clinical response to anti-LPS immunoglobulin treatments in patients in need thereof. In particular, the invention provides methods for predicting the clinical response to an anti-LPS immunoglobulin treatment in a patient in need thereof, said method comprising the steps of evaluating the expression of a predictive biomarker selected from the group consisting of CD14, CD68, TLR4, TLR7, IL6, IL8, IL10, IFN-alpha, IGF1, CXCL1, CXCL9, CXCL10, RAGE, GDNF, BCHE, and combination thereof, in said patient.

Claims

exact text as granted — not AI-modified
1 - 15 . (canceled) 
     
     
         16 . An IgY composition comprising one fraction consisting of polyclonal IgY directed against  Escherichia coli  and another fraction consisting of polyclonal IgY directed against  Salmonella typhimurium.    
     
     
         17 . The IgY composition of  claim 16 , which is obtained from egg yolk of immunized hens. 
     
     
         18 . The IgY composition of  claim 16  which is obtained by:
 a) immunizing at least 2 distinct groups of hens, one group with  E. coli  gram-negative bacteria and another group with S. typhimurium gram-negative bacteria, 
 b) obtaining IgY-containing fractions of egg yolks obtained from each of the 2 distinct groups of immunized hens, and 
 c) mixing said IgY-containing fractions obtained from the 2 distinct groups of immunized hens. 
 
     
     
         19 . The IgY composition of  claim 16 , which is an egg yolk powder formulated for oral administration. 
     
     
         20 . The IgY composition of  claim 19 , which is defatted or partially defatted. 
     
     
         21 . A method for treating chronic disease induced by CD14+ activated monocytes in peripheral blood, comprising administering a therapeutically efficient amount of an IgY composition to a patient affected with said chronic disease, wherein said chronic disease induced by CD14+ activated monocytes in peripheral blood is selected from the group consisting of:
 idiopathic chronic pain syndromes, and,   migraine, chronic head and neck deceleration trauma, epicondylitis, impingement syndrome,   wherein said IgY composition comprises one fraction consisting of polyclonal IgY directed against Escherichia coli and another fraction consisting of polyclonal IgY directed against Salmonella typhimurium.   
     
     
         22 . The method of  claim 21 , wherein said IgY composition is obtained from egg yolk of immunized hens. 
     
     
         23 . The method of  claim 21  wherein said IgY composition is obtained by:
 a) immunizing at least 2 distinct groups of hens, one group with  E. coli  gram-negative bacteria and another group with S. typhimurium gram-negative bacteria, 
 b) obtaining IgY-containing fractions of egg yolks obtained from each of the 2 distinct groups of immunized hens, and 
 c) mixing said IgY-containing fractions obtained from the 2 distinct groups of immunized hens. 
 
     
     
         24 . The method of  claim 21 , wherein said IgY composition is an egg yolk powder formulated for oral administration. 
     
     
         25 . The method of  claim 21 , wherein said IgY composition is defatted or partially defatted. 
     
     
         26 . The method of  claim 21 , wherein said IgY composition is administered orally to the patient. 
     
     
         27 . The method of  claim 21 , wherein said idiopathic chronic pain syndrome is selected from the group consisting of chronic widespread pain, fibromyalgia, frozen shoulder or adhesive capsulitis, oral mucositis, carpal tunnel syndrome, and bladder syndrome. 
     
     
         28 . The method of  claim 21 , wherein said patient is selected as a responder patient which is identified by quantifying the expression level of one or more of said biomarkers in a biological sample obtained from said patient to obtain an expression value for each quantified biomarker and comparing each obtained expression value to an expression value observed in non-responder patients, wherein a decrease of at least 10% in the obtained expression value of TLR-4, TLR-7, IL-6, IL-8, IL-10, IFN-alpha, IGF-1, CXCL1, CXCL9, CXCL10, RAGE, and/or GDNF relative to the expression value observed in non-responder patients and/or an increase of at least 10% in the obtained expression value of BCHE relative to the expression value observed in non-responder patients identifies said patient as a responder to said anti-LPS immunoglobulin drug. 
     
     
         29 . The method of  claim 28 , wherein the expression level of at least three of said biomarkers is evaluated in the patient. 
     
     
         30 . The method of  claim 28 , wherein the expression level of at five of said biomarkers is evaluated in the patient.

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