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Annual report 2003: Stallergenes
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Annual report 2003: Stallergenes. Laboratoire de Stallergenes SA ANNUAL REPORT 2004 May 12
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Characterization of wild-type recombinant Bet v 1a as a candidate vaccine against birch pollen allergy. Batard T, Didierlaurent A, Chabre H, Mothes N, Bussieres L, Bohle B, Couret MN, Ball T, Lemoine P, Tejkl MF, Chenal A et al INT ARCH ALLERGY IMMUNOL 2005 136 3 239-249
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Chenal, A.11
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34447132918
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Specific immunotherapy has long-term preventive effect of seasonal and perennial asthma: 10-year follow-up on the PAT-study
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Specific immunotherapy has long-term preventive effect of seasonal and perennial asthma: 10-year follow-up on the PAT-study. Jacobsen L, Niggemann B, Dreborg S, Ferdousi HA, Halken S, Host A, Koivikko A, Norberg LA, Valovirta E, Wahn U, Moller C et al ALLERGY 2007 62 8 943-948
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8
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77952130553
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American Academy of Allergy Asthma and Immunology (AAAAI) - 2009 Annual meeting (Part II), Washington DC, USA, 13-17 march 2009
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March 13-17
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American Academy of Allergy Asthma and Immunology (AAAAI) - 2009 Annual meeting (Part II), Washington DC, USA, 13-17 march 2009. Bielory L IDDB MEETING REPORT 2009 March 13-17
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IDDB Meeting Report
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Bielory, L.1
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77952123976
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American Academy of Allergy Asthma and Immunology (AAAAI) - 2009 Annual meeting (Part III), Washington DC, USA, 13-17 march 2009
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March 13-17
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American Academy of Allergy Asthma and Immunology (AAAAI) - 2009 Annual meeting (Part III), Washington DC, USA, 13-17 march 2009. Broide D IDDB MEETING REPORT 2009 March 13-17
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IDDB Meeting Report
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Broide, D.1
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11
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75749097934
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Safety and tolerability of recombinant Bet v 1 (rBet v 1) tablets in sublingual immunotherapy (SLIT)
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Abs, •• reports combined results from two phase I clinical trials NCT00889460; VO58.07 DK and NCT00396149; VO49.06 DK that assessed Oralair Birch 12.5 to 300 μg slIT, qd for 2 weeks except weekends in patients n = 112 with symptomatic birch pollen allergy. In the treated patient cohort n = 84, birch and/or Bet v 1 IgE and IgG4 serum antibody titers increased by 82 and 36% from baseline, respectively. In patients evaluable for safety n = 101, Oralair Birch was well tolerated up to doses of 50 μg and, in contrast, incremental doses of < 100 μg or single doses of 150 μg were not well tolerated. Patients who received Oralair Birch treatment reported treatmentemergent adverse events that were SLIT related including oropharyngeal pruritis, ear pruritis, rhinitis and pharyngeal edema
-
Safety and tolerability of recombinant Bet v 1 (rBet v 1) tablets in sublingual immunotherapy (SLIT). Winther L, Poulsen L, Robin B, Melac M, Malling H ALLERGY 2009 64 Suppl 90 Abs 341 •• reports combined results from two phase I clinical trials (NCT00889460; VO58.07 DK and NCT00396149; VO49.06 DK) that assessed Oralair Birch (12.5 to 300 μg slIT, qd for 2 weeks except weekends) in patients (n = 112) with symptomatic birch pollen allergy. In the treated patient cohort (n = 84), birch and/or Bet v 1 IgE and IgG4 serum antibody titers increased by 82 and 36% from baseline, respectively. In patients evaluable for safety (n = 101), Oralair Birch was well tolerated up to doses of 50 μg and, in contrast, incremental doses of < 100 μg or single doses of 150 μg were not well tolerated. Patients who received Oralair Birch treatment reported treatmentemergent adverse events that were SLIT related including oropharyngeal pruritis, ear pruritis, rhinitis and pharyngeal edema.
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Nct00901914: Study Of Rbet V1 Tablets
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46849093983
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Subcutaneous immunotherapy with recombinant Bet v 1 in birch allergy: Clinical and immunological effects
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Abs
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Subcutaneous immunotherapy with recombinant Bet v 1 in birch allergy: Clinical and immunological effects. Pauli G, Malling H, Rak S, Horak F, Pastorello E, Purohit A, Holst-Larsen T, Arvidsson M, Mothes N, Kavina A, Szaal S et al ALLERGY 2007 62 83 Abs 706
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Arvidsson, M.8
Mothes, N.9
Kavina, A.10
Szaal, S.11
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77952135501
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Characterization of recombinant Bet v 1 as a candidate vaccine against birch pollen allergy
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Abs
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Characterization of recombinant Bet v 1 as a candidate vaccine against birch pollen allergy. Nony E, Chabre H, Lautrette A, Lemoine P, Couret M, Bobinnec Y, Didierlaurent A, Batard T, Moingeon P ALLERGY 2008 63 Suppl 88 Abs 599
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Didierlaurent, A.7
Batard, T.8
Moingeon, P.9
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16
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66749110446
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Standardization of allergen products: 1. Detailed characterization of GmP-produced recombinant Bet v 1.0101 as biological reference preparation
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•• reports the characterization of an rBet v 1.0101 produced in accordance to GMP for the Biological standardization Program of the EDQM. The rBet V 1.0101 was 159 amino acids long and had 96.2% sequence identity with a major Bet v 1a pollen allergen record held in the swiss-Prot protein sequence database primary accession number: P15494. The rBet v 1.0101 protein was monomeric and stable when tested for up to 3 months at 4°C. In functional assays, rBet V 1.0101 exhibited allergenic potency. The EDQM selected rBet v 1.0101 as an international reference material for studies required during the clinical application of allergenic drug candidates such as Oralair Birch
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Standardization of allergen products: 1. Detailed characterization of GmP-produced recombinant Bet v 1.0101 as biological reference preparation. Himly M, Nony E, Chabre H, Van Overtvelt L, Neubauer A, van Ree R, Buchheit KH, Vieths S, Moingeon P, Ferreira F ALLERGY 2009 64 7 1038-1045 •• reports the characterization of an rBet v 1.0101 produced in accordance to GMP for the Biological standardization Program of the EDQM. The rBet V 1.0101 was 159 amino acids long and had 96.2% sequence identity with a major Bet v 1a pollen allergen record held in the swiss-Prot protein sequence database (primary accession number: P15494). The rBet v 1.0101 protein was monomeric and stable when tested for up to 3 months at 4°C. In functional assays, rBet V 1.0101 exhibited allergenic potency. The EDQM selected rBet v 1.0101 as an international reference material for studies required during the clinical application of allergenic drug candidates such as Oralair Birch.
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Buchheit, K.H.7
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Moingeon, P.9
Ferreira, F.10
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67650732297
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High throughput screening of mixed-mode sorbents and optimization using pre-packed lab-scale columns for the purification of the recombinant allergen rBet v 1a
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High throughput screening of mixed-mode sorbents and optimization using pre-packed lab-scale columns for the purification of the recombinant allergen rBet v 1a. Brochier VB, Chabre H, Lautrette A, Ravault V, Couret MN, Didierlaurent A, Moingeon P J CHROMATOGR B ANAL TECHNOL BIOMED LIFE SCI 2009 877 24 2420-2427
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77952133161
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Patterns of IgE, IgG, and skin tests responses to Bet v 1 and birch pollen extract after immunotherapy with recombinant Bet v 1
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Abs
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Patterns of IgE, IgG, and skin tests responses to Bet v 1 and birch pollen extract after immunotherapy with recombinant Bet v 1. Pauli G, Larsen T, Rak S, Horak F, Spitzauer S, Mothes N, Purohit A, Pastorello E, Arvidsson M, Kavina A, Schroeder J et al ALLERGY 2008 63 Suppl 88 Abs 488
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77952165402
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Assessing purity and integrity of pharmaceutical grade rBet v 1 using rapid separation liquid chromatography combined with on-line ultra-high resolution time of flight mass spectrometry
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Assessing purity and integrity of pharmaceutical grade rBet v 1 using rapid separation liquid chromatography combined with on-line ultra-high resolution time of flight mass spectrometry. Emmanuel N, Godat E, Lemoine P, Batard T, Didierlaurent A, Moingeon P ALLERGY 2009 64 Suppl 90 Abs 227
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75749097934
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Abs
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Safety and tolerability of recombinant Bet v 1 (rBet v 1) tablets in sublingual immunotherapy (SLIT). Winther L, Poulsen LK, Robin B, Melac M, Malling H J ALLERGY CLIN IMMUNOL 2009 123 2 Suppl 1 Abs 828
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77952123975
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The European Union biological standardization program: Detailed characterization of GmP-produced recombinant Bet v 1.0101 and Phi P 5.0109 as candidate reference standards
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Abs
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The European Union biological standardization program: Detailed characterization of GmP-produced recombinant Bet v 1.0101 and Phi P 5.0109 as candidate reference standards. Himly M, Neubauer A, Moingeon P, Cromwell O, van Ree R, Buchheit K, Vieths S, Ferreira F J ALLERGY CLIN IMMUNOL 2009 123 2 Abs 831
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49149107253
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Efficacy of recombinant birch pollen vaccine for the treatment of birch-allergic rhinoconjunctivitis
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•• Reports results from a completed phase II clinical trial NCT00410930; DV08.01 that assessed rBet v 1, a licensed birch pollen extract and nBet v 1 0 to 15 μg each allergen, SCIT weekly for 12 weeks, then 15 μg sCIT monthly for 2 years in patients n = 147 with birch pollen-related rhinoconjunctivitis and/or mild asthma. Treatment with all three allergens significantly reduced the occurrence of rhinoconjunctivitis symptoms, skin sensitivity and the use of rescue and controller medications observed by patients compared with a placebo group. After 1 and 2 years of treatment the levels of Bet v 1-specific IgG and IgG subclasses IgG1, IgG2 and IgG4 were increased in all treated groups, while no changes in Bet v 1-specific IgGE, IgA or IgG3 observed
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Efficacy of recombinant birch pollen vaccine for the treatment of birch-allergic rhinoconjunctivitis. Pauli G, Larsen TH, Rak S, Horak F, Pastorello E, Valenta R, Purohit A, Arvidsson M, Kavina A, Schroeder JW, Mothes N et al J ALLERGY CLIN IMMUNOL 2008 122 5 951-960 •• Reports results from a completed phase II clinical trial (NCT00410930; DV08.01) that assessed rBet v 1, a licensed birch pollen extract and nBet v 1 (0 to 15 μg each allergen, SCIT weekly for 12 weeks, then 15 μg sCIT monthly for 2 years) in patients (n = 147) with birch pollen-related rhinoconjunctivitis and/or mild asthma. Treatment with all three allergens significantly reduced the occurrence of rhinoconjunctivitis symptoms, skin sensitivity and the use of rescue and controller medications observed by patients compared with a placebo group. After 1 and 2 years of treatment the levels of Bet v 1-specific IgG and IgG subclasses (IgG1, IgG2 and IgG4) were increased in all treated groups, while no changes in Bet v 1-specific IgGE, IgA or IgG3 observed.
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