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( 12 ) United States Patent US009801938B2 ( 12) United States Patent ( 10 ) Patent No. : US 9 ,801 , 938 B2 Wesjohann et al. (45 ) Date of Patent: Oct. 31, 2017 EP 1125585 AL 8 / 2001 ( 54 ) USE OF AN AGENT CONSISTING OF EP 1982999 Al 10 / 2008 ANTIBODIES AND /OR INSULIN - LIKE WO WO - 92 / 16624 Al 10 / 1992 GROWTH FACTOR ANTAGONISTS WO WO - 9625155 Al 8 / 1996 (75 ) Inventors: Jan Wesjohann , Visbek (DE ) ; Günter WO WO - 0130300 A2 5 / 2001 Sprotte , Pentling -Graßlfing (DE ) ; Ana WO WO -01 / 48018 Al 7 / 2001 WO WO -0202641 Al 1 / 2002 Maria Waaga -Gasser , Würzburg (DE ) WO WO - 2008025099 A1 3 /2008 ( 73 ) Assignees: MAT-MALTA ADVANCED WO WO - 2008067234 A2 6 / 2008 TECHNOLOGIES LIMITED , St. WO WO - 2008073463 A2 6 / 2008 WO WO - 2009077993 A2 6 / 2009 Julians (MT ) ; FREISTAAT BAYERN WO WO - 2009113065 Al 9 / 2009 REPRESENTED BY WO WO - 2009151717 A2 12 / 2009 JULIUS -MAXIMILLIANS WO WO - 2010 / 125565 A2 11 / 2010 UNIVERSITÄT WÜRZBURG , WO WO - 2011036539 A1 3 / 2011 Würzburg (DE ) WO WO - 2012023051 A2 2 / 2012 Subject to any disclaimer , the term of this WO WO - 2013009843 AL 1 / 2013 patent is extended or adjusted under 35 OTHER PUBLICATIONS U . S . C . 154 (b ) by 0 days . Sprotte et al . ( translation of EP0781560 , published Jul. 2 , 1997 ). * Horikoshi Toshio et al: “ IgG Antibody from Hen Egg Yolks : ( 21 ) Appl. No .: 14 /110 , 104 Purification by Ethanol Fractionation ” , Journal of Food Science , vol. 58 , No . 4 , 1993 , p . 739 - 742, 779 , XP002678305 . (22 ) PCT Filed : Mar . 28 , 2012 Akita E . M . et al : “ Comparison of four purification methods for the production of immunoglobulins from eggs laid by hens immunized ( 86 ) PCT No .: PCT/ EP2012 / 055485 with an enterotoxigenic E . coli strain ” , Journal of Immunological Methods, vol. 160 , No . 2 , 1993 , p . 207 -214 , XP023974043 . $ 371 ( c ) ( 1 ) , Bizhanov G et al : “ A novel method , based on lithium sulfate precipitation for purification of chicken egg yolk immunoglobulin ( 2 ) , ( 4 ) Date : Dec . 19 , 2013 Y , applied to immunospecific antibodies against Sendai virus ." , Scandinavian Journal of Laboratory Animal Science , vol. 31, No . 3 , (87 ) PCT Pub . No .: WO2012 / 136534 Jan . 1 , 2004 , p . 121 - 130 , XP002589471. Yokoyama H et al : “ Passive Protective Effect of Chicken Egg Yolk PCT Pub . Date : Oct . 11 , 2012 Immunoglobulins against Experimental Enterotoxigenic Escherichia coli Infection in Neonatal Piglets” , Infection and ( 65) Prior Publication Data Immunity , vol. 60 , No. 3 , Mar. 1992 , p . 998 - 1007 , XP002109373 . Yokoyama H et al : “ A Two - Step Procedure for Purification of Hen US 2014 /0112937 A1 Apr. 24 , 2014 Egg Yolk Immunoglobulin G : Utilization of Hydroxypropylmethylcellulose Phtalate and Synthetic Affinity ( 30 ) Foreign Application Priority Data Ligand Gel ( Avid AL® ) ” , Poultry Science , vol . 72 , 1993, p . 275 - 281, XP008091830 . Yokoyama H et al : “ Oral passive immunization against experimen Apr. 5 , 2011 (DE ) .. 10 2011 006 809 tal salmonellosis in mice using chicken egg yolk antibodies specific (51 ) Int. CI. for Salmonella enteritidis and S . typhimurium ” , Vaccine, vol. 16 , No . 4 , 1998 , p . 388 - 393 , XP004099299 . CO7K 16 / 12 ( 2006 .01 ) Yokoyama H et al : “ Effect of Oral Egg Antibody in Experimental A61K 39 /40 ( 2006 .01 ) F18 Escherichia coli Infection in Weaned Pigs ” , The Journal of COZK 16 / 14 ( 2006 .01 ) Veterinary Medical Science, vol. 59, No . 10 , Oct . 1997 , p . 917 - 921, A61K 39 /00 ( 2006 .01 ) XP002678452Yokoyama K et al : “ Effects of egg yolk antibody against (52 ) U .S . CI. Porphyromonas gingivalis gingipains in periodontitis patients ” , CPC .. .. .. A61K 39 /40 ( 2013 .01 ) ; C07K 16 / 1203 Journal of Oral Science , vol . 49 , No . 3 , 2007 p . 201 - 206 , ( 2013 .01 ) ; CO7K 16 / 1232 ( 2013 . 01 ) ; COOK XP002678729 . 16 / 1235 (2013 .01 ) ; CO7K 16 / 1275 (2013 .01 ) ; Javier Hernandez -Campos F et al : “ Purification of Egg Yolk Immu noglobulin ( IgY ) by Ultrafiltration : Effect of pH , Ionic Strength , and CO7K 16 / 1282 ( 2013 .01 ) ; CO7K 16 / 14 Membrane Properties ” , Journal of Agricultural and Food Chemistry , ( 2013 .01 ) ; A61K 2039 / 507 ( 2013 .01 ) ; COOK vol. 58 , No. 1 , Jan . 2010 , p . 187 - 193, XP002678453 . 2317 / 11 ( 2013 .01 ) ; CO7K 2317 / 23 (2013 . 01 ) Suzuki H et al: “ Effect of dietary anti- Helicobacter pylori -urease immunoglobulin Y on Helicobacter pylori infection " , Alimentary ( 58 ) Field of Classification Search Pharmacology & Therapeutics , vol. 20 , (Supp . 1 ) , Jul. 2004 , p . None 185 - 192 , XP002678730 . See application file for complete search history . Kawagashira Y et al : Differential response to intravenous immuno globulin ( IVIg ) therapy among multi focal and polyneuropathy types of painful diabetic neuropathy, Journal of Clinical Neurosci ( 56 ) References Cited ence, vol. 17 , No. 8 , 2010 , p . 1003 - 1008 , XP027129028 . U . S . PATENT DOCUMENTS (Continued ) 2001/ 0055595 Al 12 / 2001 Goldenberg Primary Examiner — Brian J Gangle 2003 / 0099633 Al 5 / 2003 Campbell et al . ( 74 ) Attorney , Agent, or Firm — Polsinelli PC 2006 / 0034846 AL 2 / 2006 Ezban et al. (57 ) ABSTRACT 2007/ 0122413 AL 5 / 2007 Sivakumar et al. The present invention relates to the use of a composition selected from the group consisting of antibodies, antibody FOREIGN PATENT DOCUMENTS fragments , insulin - like growth factor antagonists , Toll - like EP 0225254 A2 6 / 1987 receptor antagonists and mixtures thereof for the treatment EP 0503293 B1 * 12 /1998 . A23B 5 / 16 or the prophylaxis of certain diseases . EP 0 955 061 Al 11/ 1999 14 Claims, 9 Drawing Sheets US 9 ,801 ,938 B2 Page 2 ( 56 ) References Cited OTHER PUBLICATIONS Cats E A et al : “ New liquid intravenous immunoglobulin ( 10 % IVIg ) for treatment of multifocal motor neuropathy ; A prospective study of efficacy, safety and tolerability ” , Journal of Neurology , vol. 255 , No . 10 , 2008 , p . 1598 - 1599, XP019657652 . Schade R et al : “ Chicken Egg Yolk Antibodies ( Igy -technology ) : A Review of Progress in Production and Use in Research and Human and Veterinary Medicine ” , Alternatives to Laboratory Animals ( ATLA . ), vol. 33 , No. 2 , 2005 , p . 129 - 154 , XP009057556 . Waaga -Gasser A . M . et al : “ Oral immunoglobulin induces mononuclear cell apoptosis in patients suffering from idiopathic chronic pain syndrome: Results from a pilot study ” , International Journal of Clinical Pharmacology and Therapeutics , vol. 47 , No. 7 , 2009 , p . 421 - 433 , XP009150941 . Struff W G et al : " Bovine colostrum as a biologic in clinical medicine : A review — Part II : Clinical Studies ” , International Jour nal of Clinical Pharmacology and Therapeutics , vol. 46 , No . 5 , 2008 , p . 211 - 225 , XP009150270 . Jennifer Kovacs and Yoshinori Mine 2005 . “ Microencapsulation for the gastric and intestinal passage controlled release of immuno globulin Y ” . Journal of Immunological Methods. vol . 296 pp . 199 - 209 . XP009186578 — Elvira Scheckies , “ Polyclonal Antibodies — An Introduction into the Theory and Practice of Antibody Production ," VCH Verlagsgesellschaft, 1996 , pp . 2 - 7 , English Translation . * cited by examiner U .S . Patentatent Oct . 31 , 2017 Sheet 1 of 9 US 9 ,801 , 938 B2 Fig.1 * * YYY mm Days NH- TTTTTTT 29 - dose x 2 Start ng46dh|zRey- w Hvoir ris- LLLLLLLLL . medicationSTART - - - LLLLLLLLL study of .Slait 10,0:1 high Pain low U. S . 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