ES2524325T3 - Anticuerpos seleccionados que se unen a aminofosfolípidos y su uso en el tratamiento del cáncer - Google Patents
Anticuerpos seleccionados que se unen a aminofosfolípidos y su uso en el tratamiento del cáncer Download PDFInfo
- Publication number
- ES2524325T3 ES2524325T3 ES10184072.6T ES10184072T ES2524325T3 ES 2524325 T3 ES2524325 T3 ES 2524325T3 ES 10184072 T ES10184072 T ES 10184072T ES 2524325 T3 ES2524325 T3 ES 2524325T3
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- Prior art keywords
- virus
- disease
- hodgkin
- aminophospholipids
- human
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- Obesity (AREA)
Abstract
Una composición que comprende un anticuerpo purificado, o fragmento de unión a antígeno o inmunoconjugado del mismo, en el que dicho anticuerpo: (a) comprende una región variable de cadena pesada que incluye los restos de aminoácidos de las regiones determinantes de la complementariedad (CDR) de las posiciones de aminoácidos 31-35 (CDR H1), 50-56 (CDR H2) y 95-102 (CDR H3) de la SEC ID Nº: 2, y una región variable de cadena ligera que incluye los restos de aminoácidos de las CDR de las posiciones de aminoácidos 24-34 (CDR L1), 50-56 (CDR L2) y 89-97 (CDR L3) de la SEC ID Nº: 4; (b) se une a fosfatidilserina en un ELISA realizado en presencia de suero al 10 % y comprende una región variable de cadena pesada que incluye la secuencia de aminoácidos de la SEC ID Nº: 2; o una región variable de cadena ligera que incluye la secuencia de aminoácidos de la SEC ID Nº: 4; o (c) se une a fosfatidilserina en un ELISA realizado en presencia de suero al 10 % y comprende una región variable de cadena pesada que incluye una variante o forma mutagenizada de la secuencia de aminoácidos de la SEC ID Nº: 2; en la que dicha variante o forma mutagenizada tiene una identidad de secuencia de aminoácidos de al menos aproximadamente 96 % con la secuencia de aminoácidos de la SEC ID Nº: 2; y una región variable de cadena ligera que incluye una variante o forma mutagenizada de la secuencia de aminoácidos de la SEC ID Nº: 4, en la que dicha variante o forma mutagenizada tiene una identidad de secuencia de aminoácidos de al menos aproximadamente 96 % con la secuencia de aminoácidos de la SEC ID Nº: 4; y en la que dicho ELISA tiene el protocolo: la placa de 96 pocillos se recubre con fosfatidilserina (FS) de la siguiente manera: - diluir la solución madre de FS en n-hexano a 10 μg/μl y mezclar bien - añadir 50 μl a cada pocillo y permitir que éste se evapore durante una hora añadir a cada pocillo 200 μl de tampón de bloqueo, donde dicho tampón de bloqueo es suero bovino al 10 % disuelto en PBS, cubrir y conservar a temperatura ambiente durante 2 horas o durante una noche a 4 ºC lavar la placa tres veces con PBS añadir anticuerpo primario a la muestra de ensayo diluido en dicho tampón de bloqueo e incubar durante 2 horas a 27 ºC lavar la placa tres veces con PBS añadir 100 μl/pocillo de anticuerpo secundario (anti-IgG de ratón, de cabra, conjugado con HRP u otro anticuerpo secundario apropiado) e incubar durante 1 hora a 37 ºC lavar la placa tres veces con PBS revelar el ELISA añadiendo 100 μl de solución reveladora a cada uno de los pocillos, revelar durante 10 minutos, después añadir a cada pocillo 100 μl de solución determinación y leer la densidad óptica 490 nm siendo la solución reveladora Na2PO4 0,2 M, 10 ml de ácido cítrico 0,1 M y un comprimido de 10 mg de o-fenilendiamina y 10 μl de peróxido de hidrógeno siendo la solución de terminación H2SO4 0,18 M.
Description
E10184072
18-11-2014
Los compuestos de otras clases químicas también se ha mostrado que inhiben la angiogénesis y se pueden usar en combinación con la presente invención. Por ejemplo, esteroides tales como los 4,9(11)-esteroides angiostáticos y los esteroides C21-oxigenados, como se describe en la Patente US No 5,972,922, se puede emplear en terapia combinada. Las Patentes US Nos 5,712,291 y 5,593,990, describen la talidomida y compuestos relacionados, 5 precursores, análogos, metabolitos y productos de hidrólisis, que también se pueden usar en combinación con la presente invención para inhibir la angiogénesis. Los compuestos de las Patentes US Nos 5,712,291 y 5,593,990, se pueden administrar por vía oral. Otras sustancias antiangiogénicas ejemplares que son útiles en relación con la terapia combinada se indican en la Tabla B. Cada uno de los agentes listados en la presente memoria son ejemplares y de ninguna manera limitantes. 10 TABLA B
- Inhibidores y Reguladores Negativos de Angiogénesis
- SUSTANCIAS
- REFERENCIAS
- Angiostatina
- O'Reilly et al., 1994
- Endostatina
- O'Reilley et al., 1997
- Fragmento de prolactina de 16kDa
- Ferrara et al., 1991; Clapp et al., 1993; D'Angelo et al., 1995; Lee et al., 1998
- Péptidos de Iaminina
- Kleinman et al., 1993; Yamamura et al., 1993; Iwamoto et al., 1996; Tryggvason, 1993
- Péptidos de fibronectina
- Grant et al., 1998; Sheu et al., 1997
- Inhibidores de metaloproteinasa tisular (TIMP 1, 2, 3, 4)
- Sang, 1998
- Inhibidores de activadores de plasminógeno (PAI-1, -2)
- Soff et al., 1995
- Factor α de necrosis tumoral (dosis alta, in vitro)
- Frater-Schroderetal., 1987
- TGF-β 1
- RayChadhury y D'Amore, 1991; Tada et al., 1994
- Interferon (IFN-α,-β, )
- Moore et al., 1998; Ungen et al., 1998
- Quimiocinas ELR- CXC; IL-12; SDF-1; MIG; Factor de plaqueta 4 (PF-4); IP- 10
- Moore et al., 1998; Hisco y Jiang, 1997; Coughlin et al., 1998; Tanaka et al., 1997
- Trombospondina (TSP)
- Good et al., 1990; Frazier, 1991; Bornstein, 1992; Tolsma et al., 1993; Sheibani y Frazier, 1995; Volpert et al., 1998
- SPARC
- Hasselaar y Sage, 1992; Lane et al., 1992; Jendraschak y Sage, 1996
- 2-Metoxiestradiol
- Fotsisetal., 1994
- Proteína relacionada con proliferina
- Jackson et al., 1994
- Suramin
- Gagliardi et al., 1992; Takano et al., 1994; Waltenberger et al., 1996; Gagliardi et al., 1998, Manetti et al., 1998
- Talidomida
- D'Amato et al., 1994; Kenyon et al., 1997; Wells, 1998
- Cortisona
- Thorpe et al., 1993; Folkman et al., 1983; Sakamotoetal., 1986
- Linomida
- Vukanovic et al., 1993; Ziche et al., 1998; Nagler et al., 1998
- Fumagilina (AGM-1470, TNP-470)
- Sipos et al., 1994; Yoshida et al., 1998
- Tamoxifeno
- Gagliardi y Collins, 1993; Under y Borden, 1997; Haran et al., 1994
- Extracto de muérdago Coreano (Viscum album coloratum)
- Yoon et al., 1995
- Retinoides
- Oikawa et al., 1989; Lingen et al., 1996; Majewski et al., 1996
- CM101
- Hellerqvist et al., 1993; Quinn et al., 1995; Wamil et al., 1997; DeVoreetaI., 1997
- Dexametasona
- Hori et al., 1996; Wolffet al., 1997
- Factor inhibidor de leucemia (LIF)
- Pepper et al., 1995
Ciertos componentes preferidos para el uso en inhibir la angiogénesis son la angiostatina, endostatina, vasculostatina, canstatina y maspina. La proteína denominada "angiostatina" se describe en las Patentes US 5,776,704, 5,639,725 y
15 5,733,876. La angiostatina es una proteína que tiene un peso molecular de entre aproximadamente 38 kD y aproximadamente 45 kD, determinado reduciendo la electroforesis en gel de poliacrilamida, que contiene aproximadamente regiones 1 a 4 de Kringle de una molécula de plasminógeno. La angiostatina generalmente tiene una secuencia de aminoácidos sustancialmente similar a la de un fragmento de plasminógeno murino que comienza en el aminoácido número 98 de una molécula de plasminógeno de murino intacta.
20 La secuencia de aminoácidos de la angiostatina varía ligeramente entre las especies. Por ejemplo, en la angiostatina humana, la secuencia de aminoácidos que es sustancialmente similar a la secuencia del fragmento de plasminógeno murino descrito anteriormente, aunque una secuencia de angiostatina humana activa puede comenzar en cualquier
52
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resultante se enlace aún al antígeno pretendido o a la FE y de tal manera que el agente unido mantenga sustancialmente la actividad biológica y/o recupere la actividad biológica cuando sea liberado de la construcción.
H1. Reticulantes bioquímicos
5 Además de la información general proporcionada anteriormente, los anticuerpos o péptidos de unión a la FE se pueden conjugar con agentes terapéuticos o con otros agentes, usando ciertos reticulantes bioquímicos preferidos. Los reactivos de reticulación se usan para formar puentes moleculares que unen entre sí grupos funcionales de dos moléculas diferentes. Para unir dos proteínas diferentes de una manera gradual, se pueden usar reticulantes
10 heterobifuncionales que eliminan la formación de homopolímeros no deseada. Los reticulantes heterobifuncionales ejemplares se presentan en la Tabla C. TABLA C
- RETICULANTES HETERO-BIFUNCIONALES
- Reticulante
- Reactivo hacia Ventajas y Aplicaciones Longitud del brazo Espaciador después de la Reticulación
- SMPT
- Aminas primarias sulfhidrilos Mayor estabilidad 11,2 A
- SPDP
- Aminas primarias sulfhidrilos TWolación Reticulación escindible 6,8 A
- LC-SPDP
- Aminas primarias sulfhidrilos Brazo espaciador extendido 15,6 A
- SuIfo-LC-SPDP
- Aminas primarias sulfhidrilos Brazo espaciador extendido Soluble en agua 15,6 A
- SMCC
- Aminas primarias sulfhidrilos Grupo reactivo maleimida estable Conjugación enzima-anticuerpo Conjugación proteína transportadora –Hapteno 11,6 A
- SuIfo-SMCC
- Aminas primarias sulfhidrilos Grupo reactivo maleimida estable Soluble en agua Conjugación enzima-anticuerpo 11,6 A
- MBS
- Aminas primarias sulfhidrilos Conjugación enzima-anticuerpo Conjugación proteína transportadora-Hapteno 9,9 A
- SuIfo-MBS
- Aminas primarias sulfhidrilos Soluble en agua 9,9 A
- SIAB
- Aminas primarias sulfhidrilos Conjugación enzima-anticuerpo 10,6 A
- SuIfo-SIAB
- Aminas primarias sulfhidrilos Soluble en agua 10,6 A
- SMPB
- Aminas primarias sulfhidrilos Brazo espaciador extendido Conjugación enzima-anticuerpo 14,5 A
- SuIfo-SMPB
- Aminas primarias sulfhidrilos Brazo Espaciador extendido Soluble en agua 14,5 A
- EDC/Sulfo-NHS
- Aminas primarias grupos carboxilo Conjugación Hapteno-Transportador 0
- ABH
- Carbohidratos no selectivos Reacciona con grupos azúcar 11,9 A
15 Los reticulantes hetero-bifuncionales contienen dos grupos reactivos: uno generalmente reacciona con un grupo amino primario (por ejemplo, N-hidroxisuccinimida) y el otro generalmente reacciona con un grupo tiol (por ejemplo, disulfuro de piridilo, maleimidas, halógenos, etc.). A través del grupo reactivo amina primario, el reticulador puede reaccionar con el/los restos de lisina de una proteína (por ejemplo, el anticuerpo, fragmento o péptido de unión a la FE, seleccionado) y a través del grupo reactivo tiol, el reticulador, ya unido a la primera proteína, reacciona con el resto de
20 cisteína (grupo sulfhidrilo libre) de la otra proteína.
Las composiciones por lo tanto generalmente tienen, o se derivan para tener, un grupo funcional disponible para propósitos de reticulación. Este requisito no se considera que sea limitante porque una amplia variedad de grupos se puede usar de esta manera. Por ejemplo, grupos amina primarios o secundarios, grupos hidrazida o hidrazina, alcohol
25 carboxílico, carbamato, fosfato, o grupos alquilantes se pueden usar para unir o reticular.
58
TABLA D
- Agentes Quimioterapéuticos Útiles en Enfermedades Neoplásicas
- CLASE
- TIPO DE AGENTE NOMBRES NO COMERCIALES (OTROS NOMBRES) ENFERMEDAD
- Agentes Alquilantes
- Mostazas de Nitrógeno Mecloretamina (HN2) Enfermedad de Hodgkin, Iinfomas no Hodgkin.
- Ciclofosfamida Ifosfamida
- Leucemias Iinfocíticas agudas y crónicas, enfermedad de Hodgkin, Iinfomas no Hodgkin, mieloma múltiple, neuroblastoma, mama, ovario, pulmón, tumor de Wilms, cuello uterino, testículos, sarcomas de tejido blando.
- Melfalan (L-sarcolisina)
- Mieloma múltiple, mama, ovario.
- Clorambucilo
- Leucemia linfocítica crónica, macroglobulinemia primaria, enfermedad de Hodgkin, Iinfomas no Hodgkin.
- Etilenimenos y Metilmelaminas
- Hexametilmelamina Ovario
- Tiotepa
- Vejiga, mama, ovario.
- Alquilsulfonatos
- Busulfán Leucemia granulocítica crónica.
- Nitrosoureas
- Carmustina (BCNU) Enfermedad de Hodgkin, Iinfomas no de Hodgkin, tumores de cerebro primarios, mieloma múltiple, melanoma maligno
- Lomustina (CCNU)
- Enfermedad de Hodgkin, Iinfomas no Hodgkin, tumores cerebrales primarios, pulmón microcítico
- Semustina (metiICCNU)
- Tumores cerebrales primarios, estómago, colon
- Estreptozocina (estreptozotocina)
- Insulinoma pancreático maligno, carcinoide maligno
- Triacinas
- Dacarbazina (DTIC; dimetiltriazenoimidazol carboxamida) Melanoma maligno, enfermedad de Hodgkin, sarcomas de tejido blando
- Antimetabolitos
- Análogos de Ácido Fólico Metotrexato (ametopterina) Leucemia linfocítica aguda, coriocarcinoma, micosis fungoide, mama, cabeza y cuello, pulmón, sarcoma osteogénico
- Análogos de Pirimidina
- Fluouracilo (5-fluoro-uracilo; 5-FU). Floxuridina (fluorodesoxiuridina; FUdR). Mama, colon, estómago, páncreas, ovario, cabeza y cuello, vejiga urinaria, lesiones de piel premalignas (tópicas)
- Citarabina (arabinósido de citosina)
- Leucemias linfocítica aguda y granulocítica aguda
- Análogos de purina e inhibidores relacionados
- Mercaptopurina (6- mercaptopurina 6-MP) Leucemias linfocítica aguda, granulocítica aguda y granulocítica crónica
- Tioguanina (6- tioguanina; TG)
- Leucemias granulocítica aguda, linfocítica aguda y granulocítica crónica
- Pentostatina (2- desoxicoformicina)
- Tricoleucemia, micosis fungoide, leucemia linfocítica crónica
- Vinblastina (VLB)
- Enfermedad de Hodgkin, Iinfomas no Hodgkin, mama, testículos
- Alcaloides de la Vinca
- Vincristina Leucemia linfocítica aguda, neuroblastoma, tumor de Wilms, rabdomiosarcoma, enfermedad de Hodgkin, Iinfomas no Hodgkin, pulmón microcítico
- Epipodofilotoxinas
- Etopósido Tertipósido Testículos, pulmón microcítico y otros pulmones, mama, enfermedad de Hodgkin, Iinfomas no Hodgkin, leucemia granulocítica aguda, sarcoma
80 81
- Agentes Quimioterapéuticos Útiles en Enfermedades Neoplásicas
- CLASE
- TIPO DE AGENTE NOMBRES NO COMERCIALES (OTROS NOMBRES) ENFERMEDAD
- Productos Naturales
- de Kaposi
- Antibióticos
- Dactinomicina (actinomicina D) Coriocarcinoma, tumor de Wilms, rabdomiosarcoma, testículos, sarcoma de Kaposi
- Daunorrubicina (daunomicina; rubidomicina)
- Leucemias granulocítica aguda y linfocítica aguda
- Doxorrubicina
- Sarcomas de tejido blando, osteogénico y otros sarcomas; enfermedad de Hodgkin, Iinfomas no Hodgkin, leucemias agudas, mama, genitourinario, tiroides, pulmón, estómago, neuroblastoma
- Bleomicina
- Testículos, cabeza y cuello, piel, esófago, pulmón y vías genitourinarias; enfermedad de Hodgkin, Iinfomas no Hodgkin
- Plicamicina (mitramicina)
- Testículos, hipercalcemia maligna
- Mitomicina (mitomicina C)
- Estómago, cuello uterino, colon, mama, páncreas, vejiga, cabeza y cuello
- Enzimas
- L-Asparaginasa Leucemia linfocítica aguda.
- Modificadores de Respuestas Biológicas
- Interferon alfa Tricoleucemia, sarcoma de Kaposi, melanoma, carcinoide, célula renal, ovario, vejiga, Iinfomas no Hodgkin, micosis fungoide, mieloma múltiple, leucemia granulocítica crónica
- Agentes diversos
- Complejos de coordinación de platino Cisplatino (cis-DDP) Carboplatino Testículos, ovario, vejiga, cabeza y cuello, pulmón, tiroides, cuello uterino, endometrio, neuroblastoma, sarcoma osteogénico
- Antracenodiona
- Mitoxantrona Leucemia granulocítica aguda, mama
- Urea sustituida
- Hidroxiurea Leucemia granulocítica crónica, policitemia vera, trombocitosis esencial, melanoma maligno
- Derivado de Metilhidrazina
- Procarbazina (N- metilhidrazina, MIH) Enfermedad de Hodgkin
- Adrenocortical
- Mitotano(o,p'-DDD) Corteza adrenal
- Supresor
- Aminoglutetimida Mama
- Hormonas y Antagonistas
- Adrenocorticosteroides Prednisona (diversas otras preparaciones equivalentes disponibles) Leucemias linfocíticas agudas y crónicas, Iinfomas no Hodgkin, enfermedad de Hodgkin, mama
- Progestinas
- Caproato de hidroxiprogesterona Acetato de medroxiprogesterona, Acetato de megestrol Endometrio, mama
- Estrógenos
- Dietilestilbestrol
- Etinilestradiol (otras preparaciones disponibles)
- Mama, próstata
- Antiestrógeno
- Tamoxifeno Mama
- Andrógenos
- Propionato de Testosterona Fluoximesterona (otras preparaciones disponibles) Mama
- Antiandrógeno
- Flutamida Próstata
- Análogo de la Hormona Liberadora de
- Leuprolide Próstata
infección y replicación viral en cualquier entorno, incluyendo el virus de importancia agrícola. El tratamiento de la infección viral y de enfermedades asociadas a invertebrados es actualmente preferido y cualquiera o más de los virus que se encuentran en la Tabla H, que infecten animales vertebrados, pueden ser inhibidos, y la infección resultante puede ser tratada usando la invención.
TABLA H
- Virus de vertebrados
- Familia
- Género Especies Tipo
- Adenoviridae
- Mastadenovirus Aviadenovirus Virus similar al virus de Ia fiebre porcina africana Adenovirus 2 humano Adenovirus 1 de aves domésticas Virus de Ia fiebre porcina africana
- Arenaviridae
- Arenavirus Arterivirus Virus de coriomeningitis linfocítica Virus de Ia arteritis equina
- Astroviridae
- Astrovirus Astrovirus 1 humano
- Birnaviridae
- Aquabirnavirus Avibirnavirus Virus de Ia necrosis pancreática infecciosa Virus de Ia enfermedad bursal infecciosa
- Bunyaviridae
- Bunyavirus Hantavirus Nairovirus Flebovirus Virus de bunyamwera Virus de Hantaan Virus de Ia enfermedad ovejuna de Nabrobi Virus siciliano de Ia fiebre Ia mosca de arena
- Caliciviridae
- Calicivirus Exantema vesicular de virus de porcino
- Circoviridae
- Circovirus Virus de Ia anemia del pollo
- Coronaviridae
- Coronavirus Torovirus Deltavirus Virus de Ia bronquitis infecciosa aviar Virus de Berne Virus de Ia hepatitis delta
- Filoviridae
- Filovirus Virus de Marburgo
- Flaviviridae
- Flavivirus Pestivirus Virus similar al de Ia hepatitis C Virus de Ia fiebre amarilla Virus de Ia diarrea bovina Virus de Ia hepatitis C
- Hepadnaviridae
- Orthofepadnavirus Avihepadnavirus Virus de Ia hepatitis B Virus de Ia hepatitis B en patos
- Subfamilia Herpesviridae Alphaherpesvirinae Subfamilia: Betaherpesvirinae Subfamilia: Gammaherpesvirinae
- Simplexvirus Varicellovirus Cytomegalovirus Muromegalovirus Roseolovirus Lymfocryptovirus Rhadinovirus Herpesvirus humano 1 Herpesvirus humano 3 Herpesvirus humano 5 Citomegalovirus de ratón 1 Herpervirus humano 6 Herpesvirus humano 4 Herpesvirus atelino 2
- Iridoviridae
- Ranavirus Lymfocystivirus Virus similar al virus del pez dorado Virus de rana 3 Virus de lenguado Virus del pez dorado 1
- Orthomyxoviridae
- Virus de la Gripe A, B Virus de la Gripe C Virus similar al Thogotovirus Virus de Ia gripe A Virus de Ia gripe C Thogotovirus
- Papovaviridae
- Polyomavirus Papillomavirus Poliomavirus de murino Papilomavirus de conejo cola de algodón (Shope)
- Subfamilia Paramyxoviridae Paramyxovirinae Subfamilia Pneumovirinae
- Paramyxovirus Morbillivirus Rubulavirus Pneumovirus Virus 1 de Ia paragripe humana Virus del Sarampión Virus de las paperas Virus sincitial respiratorio humano
- Subfamilia Parvoviridae Parovirinae
- Parvovirus Erythovirus Virus diminuto de ratones Virus B19
98
- Virus de vertebrados
- Familia
- Género Especies Tipo
- Dependovirus
- Virus 2 adenoasociado
- Picornaviridae
- Enterovirus Rinovirus Hepatovirus Cardiovirus Afthovirus Poliovirus 1 Rinovirus 1A humano Virus de Ia hepatitis A Virus de Ia encefalomiocarditis Virus O de Ia aftosa
- Subfamilia Poxviridae
- Cordopoxvirinae
- Ortopoxvirus Parapoxyvirus Avipoxvirus Capripoxvirus Leporipoxvirus Suipoxvirus Molluscipoxvirus Yatapoxvirus Virus de la vacuna Virus de Orf Poxvirus de aves domésticas Poxvirus ovino Mixomavirus Poxvirus porcino Virus contagioso de moluscos Virus de tumores del mono de Yaba
- Reoviridae
- Ortoreovirus Orbivirus Rotavirus Coltivirus Aquareovirus Reovirus 3 Virus 1 de Ia lengua azul Rotavirus de simio SA11 Virus de Ia fiebre de garrapata de colorado Virus de soleuca
- Retroviridae
- Retrovirus tipo B de mamífero Retrovirus tipo C de mamífero Retrovirus tipo C de aves Retrovirus tipo D Retrovirus Blv-htlv Lentivirus Spumavirus Virus de tumor mamario de ratón Virus de la leucemia murina Virus de la leucosis aviar Virus del mono de Mason-Pfizer Virus de la leucemia bovina Virus de inmunodeficiencia humana 1 Espumavirus humano
- Rhabdoviridae
- Vesiculovirus Lyssavirus Efemerovirus Virus de la estomatitis vesicular de indiana Virus de Ia rabia Fiebre efímera de bovino
- Togaviridae
- Alfavirus Rubivírus Virus de Sindbis Virus de la Rubéola
El uso de la invención en el tratamiento de infecciones virales y enfermedades, asociadas en mamíferos, es preferido, particularmente en términos de animales valiosos o de valor, tales como caballos de raza y mascotas domésticas, y animales y pájaros usados para producir directamente (por ejemplocarne) o para producir indirectamente (por ejemplo,
5 leche y huevos) para el consumo humano. Además del tratamiento humano, realizaciones ejemplares de la invención incluyen el tratamiento de caballos, perros, gatos y similares, el tratamiento de vacas, cerdos, jabalí, oveja, cabra, búfalo, bisonte, llama, venado, reno y otros animales grandes, así como sus crías incluyendo becerros y corderos.
El tratamiento de humanos es particularmente preferido, ya sea para virus que se presenten naturalmente o para
10 aquellos creados por bioterrorismo. En términos de virus que se presenten naturalmente y las enfermedades resultantes, la invención se encuentra nuevamente ilimitada a sus aplicaciones. Por consiguiente uno o más de los virus de la Tabla J pueden ser inhibidos usando la presente invención y las infecciones resultantes y enfermedades así tratadas.
15 TABLA J
- Enfermedades Virales en Seres Humanos
- Enfermedad
- Virus Tipo de virus
- SIDA
- Virus de Inmunodeficíencia Humana (VIH) Retrovirus
- Broncolitis y pneumonia viral
- Virus sincitial respiratorio Paramyxovirus
- Bronquiolitis
- Virus de Ia paragripe Paramyxovirus
- Cáncer de cuello uterino
- Virus del papiloma humano Papovavirus
- Varicela
- Virus Zóster de Ia varicela Herpesvirus
- Dengue
- Virus del dengue Flavivirus
- Fiebre hemorrágica de ébola
- Virus del Ébola Filovirus
- Herpes genital
- Virus-2 del herpes Simplex Herpesvirus
- Fiebre hemorrágica por Hantavirus
- Hantavirus Bunyavirus
- Hepatitis
- Hepatitis A Picornavirus
- Hepatitis B
- Hepadavirus
99
- Enfermedades Virales en Seres Humanos
- Enfermedad
- Virus Tipo de virus
- Hepatitis C
- Flavivirus
- Hepatitis D
- Deltavirus
- Hepatitis E
- Caleivirus
- Gripe
- Virus de Ia gripe A, B y C Orthotmyxovirus
- Fiebre hemorrágica Argentina de Junin
- Virus de Junin Arenavirus
- Fiebre hemorrágica de Lassa
- Virus de Lassa Arenavirus
- Enfermedad
- Virus Tipo de virus
- Fiebre hemorrágica de Machupo
- Virus de Machupo Arenavirus
- Sarampión
- Virus de Ia rubéola Paramyxovirus
- Mononucléosis
- Virus de Epstein Barr Herpesvirus
- Enfermedad por CMV (neumonía viral, síndrome similar a Ia mononucleosis)
- Citomegalovirus Herpesvirus
- Síndrome Respiratoria Aguda Severa (SARS)
- Coronavirus humano Coronavirus
- Herpes Zóster
- Virus zóster de Ia varicela Herpesvirus
- Viruela
- Virus de Ia variola Poxvirus
- Fiebre amarilla
- Virus de Ia fiebre amarilla Flavivirus
- Enfermedad del Nilo occidental
- Virus del Nilo occidental
- Encefalitis equina occidental
- Virus EE occidental Togavirus
- Neumonía, hepatitis, enfermedad respiratoria aguda
- Adenovirus Adenovirus
- Gastroenteritis
- Rotavirus Rotavirus
- Encefalitis
- Virus de Ia selva de Semliki Alfavirus
- Viruela bovina
- Virus de la vacuna Poxvirus
- Encefalitis
- EE Venezolano Alfavirus
- Enfermedad
- Virus Tipo de virus
- Meningitis, encefalitis, meningoencefalitis
- Coriomeningitis linfocítica Arenavirus
- Fiebre hemorrágica venezolana
- Virus de Guanarito Arenavirus
- Fiebre del valle del Rift (fiebre hemorrágica, encefalitis)
- Virus de Ia fiebre del valle de Rift Bunyavirus
- Fiebre hemorrágica Marburgo
- Virus de Marburgo Filovirus
- Encefalitis transmitida por garrapatas
- Virus de Ia encefalitis transmitida por garrapatas (TBEV) Flavivirus
- Encefalitis
- Virus Hendra Paramyxovirus
- Encefalitis
- Virus Nipah Paramyxovirus
- Fiebre hemorrágica de Crimea-Congo
- Virus de Ia fiebre hemorrágica de Crimea-Congo Bunyavirus
- Fiebre hemorrágica brasileña
- Virus Sabia Arenavirus
La invención se contempla particularmente para el uso en el tratamiento de las enfermedades relacionadas con el CMV tales como la neumonía viral, el síndrome similar a la mononucleosis, y malformaciones congénitas asociadas (sordera y retardo mental); enfermedades respiratorias, tales como aquellas causadas por el RSV, incluyendo la
5 bronquiolitis y neumonía viral, gripe, el resfriado común y el SARS; SIDA; hepatitis, cánceres asociados con infecciones virales; mononúcleosis; y viruela.
En otras realizaciones los inventores contemplan particularmente la inhibición de arenavirus, que son patógenos para el hombre. Los arenavirus incluyen los virus del mundo antiguo responsables de la fiebre de Lassa (virus de Lassa) y el 10 de la coriomeningitis linfocítica (LCMV). La fiebre de Lassa es endémica en Africa occidental y afecta hasta 300,000 personas anualmente y causa hasta 3,000 muertes. La infección con la fiebre de Lassa conduce a fiebre y malestar por aproximadamente 10 días. Dolor abdominal, náuseas, vómito y diarrea son comunes. Se puede desarrollar faringitis y tos. Los síntomas neurológicos son usualmente ligeros. Los síndromes de fuga vascular, tales como edema y efusiones pleurales, se encuentran presentes en casos más graves. El sangrado se observa aproximadamente en una
15 cuarta parte de los pacientes. La enfermedad puede causar cambios en el sistema cardiovascular que culminan con choque y muerte.
Los arenavirus incluyen también los virus del nuevo mundo antigénicamente distintos, responsable de la fiebre hemorrágica de Argentina (virus de Junin), fiebre hemorrágica Boliviana (virus de Machupo) y fiebre hemorrágica de 20 Venezuela (virus de Guanarito). Todos estos virus se encuentran en la lista de la categoría A de CDC de armas potenciales para bioterrorismo.
100
TABLA 10
- Localización Específica de 9D2 y Anexina V en Vasos de Tumores
- Tejido
- Anticuerpo 9D2a Control IgM de Rata Anexina Vb
- Tumores
- MDA-MB-231
- 40.6 ± 5.4 - 45.3 ± 5.6
- L540cy
- 19.3 ±3.3 - 16.7 ±3.9
- NCI-H358
- 15.6 ±4.1 - ND
- B16
- 23.4 ± 4.5 - 21.3 ±6.6
- MethA
- 25.7 ±6.8 - ND
- Normal
- Adrenal
- - - -
- Cerebro
- - - -
- Corazón
- - - -
- Riñón
- -C -C -
- Intestino
- - - -
- Hígado
- - - -
- Pulmón
- - - -
- Páncreas Bazo Testículo
- --- --- ---
- aLa locaIización del anticuerpo 9D2 y control de IgM de rata en ratones que tenían tumores se determinó por inyección del anticuerpo (50 µg), perfundiendo Ia circulación sanguínea de los ratones con solución salina y detectando el anticuerpo sobre secciones de los tejidos, usando un conjugado de anti-IgM de ratón - peroxídasa. Los resultados se presentan como el porcentaje promedio (± ET) de vasos positivos a Ia FS de vasos teñidos con MECA 32 por campo de 0.317 mm2. Se analizaron seis muestras de cada tipo. El número promedio de vasos positivos al MECA 32, por campo de 0.317 mm2 fue de 23, 25, 21, 18 y 19± 10 vasos por tumores MDA-MB-231, L540cy, H358, B16yMeth A, respectivamente.bLa localización de Ia anexina V fue determinada inyectando anexina V tratada con biotina, seguido de Ia detección en secciones congeladas usando conjugado de estreptavídinaperoxidasa. °Tinción tubular específica, no antigénica, fue visible en ambos receptores de anticuerpos 9D2 y de control.
El 9D2 y la anexina V proporcionaron esencialmente los mismos patrones de teñido. La localización del anticuerpo 9D2
5 en los vasos de tumores fue específica dado que no se observó teñido del endotelio de los tumores, con IgM de rata de especificidad irrelevante. Supuestamente, la fuga de la IgM de rata de control hacia afuera de los vasos de los tumores, ocurrió en cierto grado, pero la tinción de la IgM extravascular fue demasiado difusa o demasiado débil para discernirlo mediante inmunohistoquímica indirecta.
10 No se observó localización vascular del anticuerpo 9D2 o anexina V en nueve de diez órganos normales que fueron examinados (Tabla 10). En el riñón se observó tinción de los túbulos no pareció ser específico al antígeno. Los túbulos fueron teñidos en ambos receptores de 9D2 e IgM de rata de control, supuestamente por la secreción de IgM o sus metabolitos a través de este órgano. Los ovarios, un sitio de la angiogénesis fisiológica, no fueron examinados.
15 El porcentaje de vasos positivos a la 9D2 y anexina V varió desde 40% en tumores MDA-MB-231 hasta 15% en tumores H358. Los vasos positivos a fosfolípidos aniónicos estuvieron presentes sobre la superficie luminal de capilares y vasos en todas las regiones de los tumores pero fueron particularmente prevalecientes en y alrededor de regiones de necrosis. La mayoría de los vasos positivos o fosfolípidos aniónicos no mostraron anormalidades morfológicas que fueron evidentes mediante el microscopio óptico. Vasos ocasionales, particularmente aquellos
20 localizados en áreas necróticas, mostraron signos morfológicos de deterioro. El anticuerpo 9D2 y la anexina V se localizaron también en células tumorales necróticas y apoptóticas mientras que la localización de la IgM de control no fue detectable (Fig. 4).
Estos descubrimientos demuestran que los fosfolípidos aniónicos se encuentran presentes sobre la superficie luminal 25 de células endoteliales vasculares en varios tumores pero no en tejidos normales.
6. Estudios de Doble Tinción
También se llevaron a cabo estudios de doble tinción en los que ratones que tenían tumores de mama MDA-MB- 231,
30 ortotópicos, fueron inyectados por vía intravenosa con anticuerpo 9D2 tratado con biotina, IgM de control tratada con biotina o anexina V tratada con biotina. Una hora después los ratones se desangraron y sus tumores se extirparon y se cortaron secciones congeladas. Las secciones de tumores se tiñeron después con estreptavidina conjugada a Cy3, para detectar las proteínas tratadas con biotina y con MECA 32 conjugado a FITC, para detectar el endotelio vascular. Este método de detección marcó las proteínas tratadas con biotina y el endotelio vascular, en rojo y verde. Cuando las
35 proteínas tratadas con biotina se unieron al endotelio, la imagen de convergencia apareció de color amarillo.
118
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- 2011-06-28 HK HK11106666.7A patent/HK1152491A1/xx not_active IP Right Cessation
- 2011-07-26 JP JP2011163732A patent/JP2011213737A/ja not_active Withdrawn
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2012
- 2012-12-26 IL IL223908A patent/IL223908A/en active IP Right Grant
- 2012-12-26 IL IL223907A patent/IL223907A/en active IP Right Grant
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2013
- 2013-08-08 JP JP2013165247A patent/JP5781571B2/ja not_active Expired - Fee Related
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2015
- 2015-01-30 HK HK15101051.7A patent/HK1200360A1/xx not_active IP Right Cessation
- 2015-02-26 JP JP2015036157A patent/JP2015134791A/ja not_active Withdrawn
- 2015-03-25 HK HK15103048.9A patent/HK1202561A1/xx unknown
- 2015-03-26 HK HK15103089.9A patent/HK1202437A1/xx not_active IP Right Cessation
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2016
- 2016-04-28 JP JP2016090246A patent/JP6188258B2/ja not_active Expired - Fee Related
- 2016-06-03 JP JP2016111546A patent/JP2016164197A/ja not_active Withdrawn
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