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    STABLE LIQUID INTERFERON FORMULATIONS
    41.
    发明申请
    STABLE LIQUID INTERFERON FORMULATIONS 有权
    稳定液体干扰素制剂

    公开(公告)号：US20150093359A1

    公开(公告)日：2015-04-02

    申请号：US14564637

    申请日：2014-12-09

    Applicant: Biogen Idec MA Inc.

    Inventor： Mary D. DiBiase ,  Wen-Li Chung ,  Mark Staples ,  Eric Scharin

    IPC: A61K38/21 ,  A61K47/10 ,  A61K47/18

    CPC classification number: A61K38/215 ,  A61K9/0019 ,  A61K38/21 ,  A61K47/10 ,  A61K47/183 ,  C07K14/565

    Abstract: Liquid interferon compositions having a pH between 4.0 and 7.2 are described. The compositions comprise interferon-beta and a stabilizing agent at between about 0.3% and 5% by weight which is an amino acid selected from the group consisting of acidic amino acids, arginine and glycine. If needed, salt is added to provide sufficient ionic strength. The liquid composition has not been previously lyophilized or previously cavitated. The liquid is preferably contained within a vessel having at least one surface in contract with the liquid that is coated with a material inert to adsorption of interferon-beta. A kit for parenteral administration of a liquid interferon formulation and a method for stabilizing liquid interferon compositions are also described.

    Abstract translation: 描述pH在4.0和7.2之间的液体干扰素组合物。 所述组合物包含约0.3％至5％重量的干扰素-β和稳定剂，其为选自酸性氨基酸，精氨酸和甘氨酸的氨基酸。 如果需要，加入盐以提供足够的离子强度。 液体组合物以前没有冻干或先前被气蚀。 液体优选包含在具有至少一个与液体收缩的表面的容器中，该表面涂覆有对吸附干扰素-β无惰性的物质。 还描述了用于液体干扰素制剂的肠胃外给药的试剂盒和用于稳定液体干扰素组合物的方法。

    Stable liquid interferon beta formulations
    44.
    发明授权
    Stable liquid interferon beta formulations 有权
    稳定的液体干扰素β配方

    公开(公告)号：US08932574B2

    公开(公告)日：2015-01-13

    申请号：US13944569

    申请日：2013-07-17

    Applicant: Biogen Idec MA Inc.

    Inventor： Mary D. DiBiase ,  Wen-Li Chung ,  Mark Staples ,  Eric Scharin

    IPC: A61K38/21 ,  A61K38/00 ,  C07K14/565 ,  A61K9/00 ,  A61K47/18

    CPC classification number: A61K38/215 ,  A61K9/0019 ,  A61K38/21 ,  A61K47/10 ,  A61K47/183 ,  C07K14/565

    Abstract: Liquid interferon compositions having a pH between 4.0 and 7.2 are described. The compositions comprise interferon-beta and a stabilizing agent at between about 0.3% and 5% by weight which is an amino acid selected from the group consisting of acidic amino acids, arginine and glycine. If needed, salt is added to provide sufficient ionic strength. The liquid composition has not been previously lyophilized or previously cavitated. The liquid is preferably contained within a vessel having at least one surface in contract with the liquid that is coated with a material inert to adsorption of interferon-beta. A kit for parenteral administration of a liquid interferon formulation and a method for stabilizing liquid interferon compositions are also described.

    Abstract translation: 描述pH在4.0和7.2之间的液体干扰素组合物。 所述组合物包含约0.3％至5％重量的干扰素-β和稳定剂，其为选自酸性氨基酸，精氨酸和甘氨酸的氨基酸。 如果需要，加入盐以提供足够的离子强度。 液体组合物以前没有冻干或先前被气蚀。 液体优选包含在具有至少一个与液体收缩的表面的容器中，该表面涂覆有对吸附干扰素-β无惰性的物质。 还描述了用于液体干扰素制剂的肠胃外给药的试剂盒和用于稳定液体干扰素组合物的方法。

    Anti-Alpha(v)Beta(6) Antibodies and Uses Thereof
    46.
    发明申请
    Anti-Alpha(v)Beta(6) Antibodies and Uses Thereof 审中-公开
    抗Alpha（v）Beta（6）抗体及其用途

    公开(公告)号：US20140294809A1

    公开(公告)日：2014-10-02

    申请号：US14161207

    申请日：2014-01-22

    Applicant: BIOGEN IDEC MA INC.

    Inventor： Shelia M. Violette ,  Louise A. Koopman ,  Kenneth J. Simon ,  Paul H. Weinreb ,  Herman W.T. Van Vlijmen ,  Jose W. Saldanha ,  Alexey A. Lugovskoy

    IPC: C07K16/28

    CPC classification number: C07K16/2839 ,  A61K2039/505 ,  A61K2039/545 ,  C07K16/30 ,  C07K2317/24 ,  C07K2317/41 ,  C07K2317/567 ,  C07K2317/76 ,  C07K2317/77 ,  G01N33/57407 ,  G01N33/57492 ,  G01N33/6893 ,  G01N2333/70546 ,  G01N2800/085 ,  G01N2800/12 ,  G01N2800/20 ,  G01N2800/347 ,  Y10S424/80 ,  Y10S424/801

    Abstract: The present invention is in the fields of cell biology, immunology and oncology. The invention provides humanized antibodies that recognize αvβ6 integrins, which antibodies comprise a variable region of nonhuman origin and at least a portion of an immunoglobulin of human origin. The invention also provides methods for preparation of such antibodies, pharmaceutical compositions comprising them, and methods of treating, diagnosing and/or preventing various diseases and disorders by administering the humanized anti-αvβ6 antibodies of the invention. The invention also relates to the identification of differential expression of the integrin αvβ6 on the surfaces of tumor cells and tissues, the use of this differential expression in determining the metastatic potential of tumor cells, and methods of diagnosis and treatment/prevention of tumor metastasis and for elimination of residual metastatic tumor cells using ligands, particularly antibodies, that bind to integrin αvβ6.

    Abstract translation: 本发明涉及细胞生物学，免疫学和肿瘤学领域。 本发明提供识别αv和bgr6整联蛋白的人源化抗体，所述抗体包含非人来源的可变区和至少一部分人源免疫球蛋白。 本发明还提供了制备这些抗体的方法，包含它们的药物组合物，以及通过施用本发明的人源化抗αv和bgr6抗体来治疗，诊断和/或预防各种疾病和病症的方法。 本发明还涉及确定肿瘤细胞和组织表面的整合素αv和bgr6的差异表达，使用该差异表达来确定肿瘤细胞的转移潜能，以及诊断和治疗/预防肿瘤的方法 转移和消除残留的转移性肿瘤细胞，使用结合整联蛋白αv＆bgr的配体，特别是抗体。

    Sp35 Antibodies and Uses Thereof
    48.
    发明申请
    Sp35 Antibodies and Uses Thereof 审中-公开
    Sp35抗体及其用途

    公开(公告)号：US20140199315A1

    公开(公告)日：2014-07-17

    申请号：US14078270

    申请日：2013-11-12

    Applicant: Biogen Idec MA Inc.

    Inventor： Sha MI ,  R. Blake Pepinsky ,  Zhaohui Shao ,  Christilyn Graff

    IPC: C07K16/18 ,  A61K47/48

    CPC classification number: C07K16/28 ,  A61K2039/505 ,  C07K16/18 ,  C07K16/2803 ,  C07K2317/21 ,  C07K2317/24 ,  C07K2317/33 ,  C07K2317/55 ,  C07K2317/75 ,  C07K2317/76 ,  C07K2319/30 ,  C12N15/1138 ,  C12N2310/111 ,  C12N2310/14

    Abstract: Endogenous Sp35 is a negative regulator for neuronal survival, axon regeneration, oligodendrocyte differentiation and myelination (Negative Regulator). Molecules that block endogenous Sp35 function, such anti-Sp35 antibodies can be used as therapeutics for the treatment of neuron and oligodendrocyte dysfunction. The present invention provides antibodies specific for Sp35, and methods of using such antibodies as antagonists of endogenous Sp35 function. The invention further provides specific hybridoma and phage library-derived monoclonal antibodies, nucleic acids encoding these antibodies, and vectors and host cells comprising these antibodies. The invention further provides methods of promoting oligodendrocyte survival and myelination in a vertebrate, comprising administering to a vertebrate in need of such treatment an effective amount of an anti-Sp35 antibody

    Abstract translation: 内源性Sp35是神经元存活，轴突再生，少突胶质细胞分化和髓鞘形成（负调节因子）的负调节因子。 阻断内源性Sp35功能的分子，这种抗Sp35抗体可以用作治疗神经元和少突胶质细胞功能障碍的治疗剂。 本发明提供对Sp35特异性的抗体，以及使用抗体作为内源性Sp35功能拮抗剂的方法。 本发明还提供特异性杂交瘤和源自噬菌体文库的单克隆抗体，编码这些抗体的核酸，以及包含这些抗体的载体和宿主细胞。 本发明进一步提供了在脊椎动物中促进少突胶质细胞存活和髓鞘形成的方法，包括向需要这种治疗的脊椎动物施用有效量的抗Sp35抗体

    Compositions and methods for inhibiting growth of SMAD4-deficient cancers
    50.
    再颁专利
    Compositions and methods for inhibiting growth of SMAD4-deficient cancers 有权
    用于抑制SMAD4缺陷型癌症生长的组合物和方法

    公开(公告)号：USRE44681E1

    公开(公告)日：2013-12-31

    申请号：US13863646

    申请日：2013-04-16

    Applicant: Biogen Idec MA Inc.

    Inventor： Shelia M. Violette ,  Louise A. Koopman

    IPC: A61K39/395 ,  C07K16/00

    CPC classification number: G01N33/5011 ,  A61K38/1793 ,  A61K39/39558 ,  A61K2039/505 ,  C07K16/2839 ,  C07K2317/73 ,  G01N33/5091 ,  G01N33/574 ,  G01N33/57407 ,  A61K2300/00

    Abstract: The present invention is in the fields of cell biology, immunology and oncology. The invention relates to the discovery that there is a relationship between the expression levels of the tumor suppressor gene smad4 (also known as dpc4) and integrin ανβ6, and the responsiveness of patient populations to ανβ6-active compounds and compositions (e.g., antibodies and other ligands that bind ανβ6), particularly in cancer cells from such patient populations, more particularly on carcinomas such as pancreatic carcinomas. The invention thus provides methods for determining the responsiveness of tumor cells (particularly those from pancreatic tumors) to such ανβ6-active compounds and compositions by examining the expression of ≢νβ6 and smad4 by the tumor cells, as well as methods of diagnosis and treatment/prevention of tumor progression using ligands, including antibodies and molecule drugs, that bind to integrin ανβ6 on the surfaces of tumor cells and/or that block one or more components of the TGF-β pathway, particularly in smad4-deficient tumor cells.

    Abstract translation: 本发明涉及细胞生物学，免疫学和肿瘤学领域。 本发明涉及以下发现：肿瘤抑制基因smad4（也称为dpc4）和整联蛋白alphaneta6的表达水平之间存在关系，以及患者群体对α6β6活性化合物和组合物（例如，抗体和其他 特别是在来自这些患者群体的癌细胞中，更特别地涉及癌如胰腺癌的配体。 因此，本发明提供了通过检查肿瘤细胞的alphav nubeta6和smad4的表达以及诊断和治疗方法来确定肿瘤细胞（特别是来自胰腺肿瘤的肿瘤细胞）对这种α6β6活性化合物和组合物的反应性的方法 /使用与肿瘤细胞表面上的整联蛋白α2β6结合的配体（包括抗体和分子药物）预防肿瘤进展和/或阻断TGF-β途径的一个或多个成分，特别是在smad4缺陷型肿瘤细胞中。

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