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( 12 ) United States Patent US010206957B2 (12 ) United States Patent (10 ) Patent No. : US 10 , 206 , 957 B2 Myles et al . (45 ) Date of Patent: Feb . 19, 2019 ( 54 ) USE OF GRAM NEGATIVE SPECIES TO 6 ,974 ,585 B2 12 /2005 Askill 9 , 173 ,910 B2 11 /2015 Kaplan et al. TREAT ATOPIC DERMATITIS 2017 /0202889 AL 7 / 2017 Lang et al. (71 ) Applicant : THE UNITED STATES OF AMERICA , AS REPRESENTED BY FOREIGN PATENT DOCUMENTS THE SECRETARY , DEPARTMENT EP 1786445 A2 5 /2007 OF HEALTH AND HUMAN WO WO - 9510999 AL 4 / 1995 SERVICES, NATIONAL INSTITUTE WO WO - 03047533 A2 6 / 2003 OF HEALTH , Washington , DC (US ) WO WO - 2006048747 A1 5 / 2006 Wo WO - 2012150269 AL 11 / 2012 (72 ) Inventors: Ian Antheni Myles , Bethesda, MD WO WO - 2017184601 A1 10 /2017 (US ) ; Sandip K . Datta , Bethesda, MD (US ) OTHER PUBLICATIONS (73 ) Assignee : THE UNITED STATES OF Asher et al. Worldwide time trends in the prevalence of symptoms AMERICA , AS REPRESENTED BY of asthma , allergic rhinoconjunctivitis , and eczema in childhood : THE SECRETARY, DEPARTMENT ISAAC Phases One and Three repeat multicountry cross- sectional OF HEALTH AND HUMAN surveys . Lancet 368 : 733 - 743 (2006 ) . SERVICES , Washington , DC (US ) Avis . Chapter 87 : Parenteral Preparations. Remington : The Science and Practice of Pharmacy, 19th Ed . (Easton , PA : Mack Publishing Co . ) (p . 1530 ) ( 1995 ) . ( * ) Notice : Subject to any disclaimer , the term of this Bantz et al. The Atopic March : Progression from Atopic Dermatitis patent is extended or adjusted under 35 to Allergic Rhinitis and Asthma. J Clin Cell Immunol 5 ( 2 ) :202 U . S . C . 154 ( b ) by 0 days . ( 2014 ) . Barnes et al . An update on the genetics of atopic dermatitis : (21 ) Appl. No. : 16 /014 ,971 scratching the surface in 2009 . J Allergy Clin Immunol 125 : 16 - 31 ( 2010 ) . (22 ) Filed : Jun . 21, 2018 Bilal et al . Pattern of Bacterial Colonization of Atopic Dermatitis in Saudi Children . J Clin Diagn Res . 7 ( 9 ) : 1968 - 1970 ( 2013 ) . ( 65 ) Prior Publication Data Bin et al. Genetic and epigenetic studies of atopic dermatitis . US 2018 /0296612 A1 Oct. 18 , 2018 Allergy Asthma Clin Immunol 12 : 52 ( 2016 ) . Bogdanffy et al .Metabolism of Dibasic Esters by Rat Natal Mucosal Related U . S . Application Data Carboxylesterase . Drug Metab Dispos 19 ( 1 ) : 124 - 129 ( 1991) . Boguniewicz et al . Recent insights into atopic dermatitis and (60 ) Division of application No . 15 / 939, 066 , filed on Mar. implications for management of infectious complications. J Allergy 28 , 2018 , which is a continuation of application No . Clin Immunol 125 ( 1 ) : 4 - 19 ( 2010 ) . PCT/ US2017 /028133 , filed on Apr. 18 , 2017 . Boguniewicz et al . The ABC ' s of managing patients with severe atopic dermatitis . J Allergy Clin Immunol 132 ( 2 ) :511 - 2 .e5 ( 2013 ). (60 ) Provisional application No . 62 /324 ,762 , filed on Apr. Brauweiler et al . The cytokines increase Staphylococcus aureus 19 , 2016 . alpha toxin - induced keratinocyte death through the signal trans ducer and activator of transcription 6 ( STAT6 ) . J Invest Dermatol (51 ) Int. Ci. 134 ( 8 ) :2114 -2121 ( 2014 ). A61K 35 /66 ( 2015 .01 ) Co -pending U . S . Appl. No . 15/ 939 ,066 , filed Mar. 28, 2018 . A61K 35 / 74 ( 2015 . 01 ) Czarnowicki et al. Novel concepts of prevention and treatment of A61P 17 /04 ( 2006 . 01 ) atopic dermatitis through barrier and immune manipulations with A61K 9 / 00 ( 2006 .01 ) implications for the atopic march . JAllergy Clin Immunol 139 ( 6 ) : 1723 A61K 9 / 06 ( 2006 .01 ) 1734 ( 2017 ) . ( 52 ) U . S . CI. Dé et al . Clinical significance of Roseomonas species isolated from CPC . .. .. .. A61K 35 / 74 ( 2013 .01 ) ; A61K 9 /0014 catheter and blood samples : analysis of 36 cases in patients with ( 2013 .01 ) ; A61K 9 / 06 ( 2013 .01 ) ; A61P 17 /04 cancer. Clin Infect Dis 38 ( 11) : 1579 - 1584 (2004 ) . (2018 .01 ) (Continued ) (58 ) Field of Classification Search CPC .. A61K 35 / 74 ; A61K 9 / 0014 ; A61P 17/ 04 Primary Examiner — Satyendra K Singh See application file for complete search history . ( 74 ) Attorney , Agent, or Firm — Wilson Sonsini Goodrich & Rosati ( 56 ) References Cited (57 ) ABSTRACT U . S . PATENT DOCUMENTS Pharmaceutical compositions are disclosed that includes a 3 , 832 , 253 A 8 / 1974 Di Palma et al . therapeutically effective amount of a purified viable gram 3 , 854 ,480 A 12 / 1974 Zaffaroni negative bacteria and a pharmaceutically acceptable carrier. 4 ,452 , 775 A 6 / 1984 Kent The pharmaceutical compositions are formulated for topical 4 ,667 , 014 A 5 / 1987 Nestor, Jr. et al . 4 , 748 , 034 A 5 / 1988 De Rham administration . Methods of treating atopic dermatitis using 4 ,829 ,000 A 5 / 1989 Kleinman et al . these pharmaceutical compositions are also disclosed . 5 , 239 ,660 A 8 / 1993 Ooi 6 ,218 , 371 B1 4 /2001 Krieg et al. 13 Claims, 11 Drawing Sheets US 10 ,206 ,957 B2 Page 2 (56 ) References Cited Latvala et al. Trends in prevalence of asthma and allergy in Finnish young men : nationwide study, 1966 -2003 . BMJ 330 (7501 ) : 1186 1187 ( 2005 ) . OTHER PUBLICATIONS Lau et al. A rapid matrix - assisted laser desorption ionization - time of flight mass spectrometry - based method for single -plasmid tracking Di Nardo et al . Ceramide and cholesterol composition of the skin of in an outbreak of carbapenem - resistant Enterobacteriaceae . J Clin patients with atopic dermatitis . Acta Derm Venereol 78 ( 1 ) : 27 - 30 Microbiol 52 : 2804 - 2812 (2014 ) . ( 1998 ) . Lau et al. Development of a clinically comprehensive database and Dinulos et al. New science and treatment paradigms for atopic a simple procedure for identification of molds from solid media by dermatitis . Curr Opin Pediatr 30 ( 1 ) : 161 - 168 (2018 ) . matrix -assisted laser desorption ionization - time of flight mass spec Dolgin . First eczema biologic debuts but price could restrict use . trometry . J Clin Microbiol 51 :828 - 834 ( 2013 ) . Nat Biotechnol 35 ( 5 ) :391 -392 ( 2017 ) . Leloup et al . Outpatient Home- based Wet Wrap Dressings with Dréno et al. Microbiome in healthy skin , update for dermatologists . Topical Steroids with Children with Severe Recalcitrant Atopic J Eur Acad Dermatol Venereol 30 ( 12 ) :2038 - 2047 ( 2016 ) . Dermatitis : A Feasibility Pilot Study. Pediatr Dermatol 32 ( 4 ) :e177 Eichenfield et al . Current guidelines for the evaluation and man 178 (2015 ) . agement of atopic dermatitis : A comparison of the Joint Task Force Lewis - Jones . Quality of life and childhood atopic dermatitis : the Practice Parameter and American Academy of Dermatology guide misery of living with childhood eczema. Int J Clin Pract 60 ( 8 ): 984 lines . J Allergy Clin Immunol 139 (45 ) : S49 - S57 ( 2017 ) . 992 ( 2006 ) . Eichenfield et al. Guidelines of Care for the Management of Atopic Li et al. Altered composition of epidermal lipids correlates with Dermatitis : Part 2 : Management and Treatment of Atopic Dermatitis Staphylococcus aureus colonization status in atopic dermatitis . Br J with Topical Therapies . J Am Acad Dermatol 71 ( 1 ) : 116 - 132 (2014 ) . Dermatol 177 ( 4 ) :e125 - e127 (2017 ) . Follin et al. A skin chamber technique as a human model for studies Li et al . Topical vitamin D3 and low - calcemic analogs induce of aseptic inflammatory reactions. Method Mol Biol 412 : 333 -346 thymic stromal lymphopoietin in mouse keratinocytes and trigger an ( 2007 ) . atopic dermatitis . PNAS USA 103 ( 31 ) : 11736 - 11741 ( 2006 ) . Gerding et al. Administration of Spores of Nontoxigenic Clostridium Lyons et al. Atopic dermatitis in children : clinical features , pathophysiol difficile Strain M3 for Prevention of Recurrent C difficile Infection : ogy , and treatment . Immunol Allergy Clin North Am 35 : 161 - 183 A Randomized Clinical Trial. JAMA 313 ( 17 ) : 1719 - 1727 (2015 ) . ( 2015 ) . Gittler et al . Bathing and Associated Treatment in Atopic Derma Margolis et al . Persistence of mild to moderate atopic dermatitis . titis . Am J Clin Dermatol 18 : 45 -57 ( 2017 ) . JAMA Dermatol . 150 (6 ) :593 -600 ( 2014 ) . Grice et al. The Skin Microbiome. Nature 9 : 244 -253 (2011 ) . Mennini et al. Two Phase 3 Trials of Dupilumab versus Placebo in Gueniche et al . Effects of nonpathogenic gram -negative bacterium Atopic Dermatitis . N Engl J Med 376 ( 11 ) : 1090 ( 2017 ) . Vitreoscilla filiformis lysate on atopic dermatitis : a prospective , Michon et al. Bacteremia due to imipenem -resistant Roseomonas randomized , double -blind , placebo -controlled clinical study . Br J mucosa in a child with acute lymphoblastic leukemia . J Pediatr Dermatol 159 : 1357 - 1363 ( 2008 ) . Hematol Oncol. 36 ( 3 ) :e165 - 168 ( 2014 ) . Henderson et al. The burden of disease associated with filaggrin Miller et al . Vitamin D and innate immunity . Dermatol Ther mutations : A population -based , longitudinal birth cohort study . J 23 : 13 - 22 ( 2010 ) . Allergy Clin Immunol 121( 4 ) : 872 - 877 .e9 ( 2008 ) . Miyamoto - Shinohara et al. Survival of freeze - dried bacteria . J Gen Hon et al . Barrier repair therapy in atopic dermatitis : an overview . Appl Microbiol 54 ( 1 ) : 9 -24 ( 2008 ) . Am J Clin Dermatol 14 ( 5 ) :389 - 399 ( 2013 ) . Msika et al . New emollient with topical corticosteroid - sparing effect Hsu et al . Intermediate phenotypes in patients with autosomal in treatment of childhood atopic dermatitis : SCORAD and quality dominant hyper - IgE syndrome caused by somatic mosaicism . J of life improvement. Pediatr Dermatol 25 ( 6 ) :606 -612 (2008 ) . Allergy Clin Immunol 131 (6 ) : 1586 - 1593 ( 2013 ) . Muthuri et al . Impact of neuraminidase
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