ES2630406T3 - Composición y procedimientos para el tratamiento de la retinopatía diabética - Google Patents
Composición y procedimientos para el tratamiento de la retinopatía diabética Download PDFInfo
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- ES2630406T3 ES2630406T3 ES08842113.6T ES08842113T ES2630406T3 ES 2630406 T3 ES2630406 T3 ES 2630406T3 ES 08842113 T ES08842113 T ES 08842113T ES 2630406 T3 ES2630406 T3 ES 2630406T3
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Abstract
Un agente terapéutico que inhibe la interacción de LFA-1 y una ICAM para su uso en el tratamiento de la retinopatía diabética, en el que el agente terapéutico tiene la fórmula IIB, o sus sales o ésteres farmacéuticamente aceptables, **Fórmula** AR1 es un resto arilo, heteroarilo, alquilarilo, alquilheteroarilo, alicíclico o heterocíclico monocíclico o policíclico; en la que R17 es hidrógeno, sales o ésteres farmacéuticamente aceptables; y en la que R27 es **Fórmula**
Description
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Composiciones y procedimientos para el tratamiento de la retinopatfa diabetica
DESCRIPCION
Referencia cruzada
Esta solicitud reivindica beneficio sobre la solicitud provisional de EE.UU. numero de serie 60/999571, presentada el 19 de octubre de 2007.
Antecedentes de la invencion
En todo el mundo, una de las causas mas importantes de ceguera es la retinopatfa diabetica (RD), que a menudo incluye un trastorno asociado, el edema macular diabetico (EMD), que es una de las complicaciones de la diabetes que da lugar a dano, lesion y degeneracion de la microvasculatura en el cuerpo y, en particular, en el ojo. La perdida de funcion de lugar de trabajo y personal con posterioridad a dicha perdida de la funcion visual puede tener un impacto devastador sobre la persona y en la comunidad que rodea a dicho individuo como un todo. Casi todos los individuos con diabetes demuestran algun grado de retinopatfa diabetica y el numero de pacientes diabeticos es cada vez mayor, por lo tanto, existe la necesidad de tratamientos mas eficaces para la perdida de la vision y los sfntomas de la RD y el edema macular asociado.
En el documento US2004/028648 se divulga un procedimiento de tratamiento de la retinopatfa diabetica mediante la administracion de una cantidad eficaz de un antagonista de LFA-1 en una formulacion farmaceuticamente aceptable.
Sumario de la invencion
Las materias sujeto que no estan abarcadas por el alcance de las reivindicaciones no forman parte de la presente invencion reivindicada.
En un aspecto, la presente invencion proporciona un agente terapeutico para su uso en el tratamiento de la retinopatfa diabetica de acuerdo con la reivindicacion 1, que inhibe la interaccion de LFA-I y un ICAM.
Se describe un procedimiento para tratar un sujeto que sufre edema macular, que comprende administrar a dicho sujeto que lo necesita una cantidad terapeuticamente eficaz de un agente terapeutico que inhibe la interaccion de LFA-1 y un ICAM, reduciendo y / o previniendo de este mod. el edema macular en un ojo de dicho sujeto.
Se describe un procedimiento para tratar la retinopatfa diabetica en un sujeto, que comprende realizar una prueba diagnostica de retinopatfa diabetica sobre dicho sujeto; determinar si dicho sujeto sufre retinopatfa diabetica segun en los resultados de dicha prueba de diagnostico; y, tras el diagnostico de dicha retinopatfa diabetica, administrar a dicho sujeto una cantidad eficaz de un antagonista (LFA-1) en una formulacion farmaceuticamente aceptable. Se describe un procedimiento para reducir y / o prevenir la inflamacion ocular postoperatoria en un sujeto que sufre diabetes, que comprende administrar a dicho sujeto que lo necesite una cantidad terapeuticamente eficaz de un antagonista de LFA-1, reduciendo y / o previniendo de este modo la inflamacion postoperatoria en un ojo de dicho sujeto.
En algunos ejemplos, la inflamacion postoperatoria es el resultado de vitrectomfa, terapia de fotocoagulacion con laser, terapia fotodinamica o LASIK. En otros ejemplos, la etapa de diagnostico se realiza mediante la formacion de imagenes de un ojo de dicho sujeto o el analisis de una muestra biologica de un ojo de dicho sujeto.
En algunas de las realizaciones de la invencion, el ICAM es ICAM-1, ICAM-2 o ICAM-3. En algunas realizaciones, el ICAM es ICAM-1. En algunas realizaciones de la invencion, el agente terapeutico es un antagonista de LFA-1. En algunas de las realizaciones de la invencion, el antagonista de LFA-1 se une a un sitio de union de alta afinidad en la subunidad aL de LFA-1 que se superpone al sitio de union a ICAM-1. En otras realizaciones de la invencion, el antagonista de LFA-1 es directamente competidor con la union de ICAM-1 en la subunidad aL de LFA-1. En algunas realizaciones de la invencion, el antagonista de LFA-1 es un inhibidor competitivo de la interaccion entre LFA-1 e ICAM-1. En algunas realizaciones de la invencion, el antagonista de LFA-1 es un antagonista alosterico de la union de ICAM-1 en la subunidad aL de LFA-1.
En algunos de los ejemplos, la retinopatfa diabetica es no proliferativa, en algunos, la retinopatfa diabetica es proliferativa. En algunas realizaciones de la invencion, el dano resultante de la retinopatfa diabetica es edema macular, neovascularizacion de la retina, crecimiento fibrovascular sobre una retina, perdida de la vision, engrosamiento de la membrana basal, edema de retina o isquemia retiniana.
En algunos de los ejemplos, se proporciona un antagonista de LFA que es un anticuerpo. En algunas de las realizaciones de la invencion, se proporciona un antagonista de LFA que es un compuesto de Formula II.
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Formula I
Formula II
Formula III
W _ QH Rr W, R30
Formula IV Formula V Formula VI
Se proporciona el compuesto de Formula II que contiene una estereoqmmica como en la Formula II'.
Formula II
En algunos de los ejemplos, se proporciona el compuesto de Formula III que contiene una estereoqufmica como en la Formula III'.
Formula III'
En algunas de las realizaciones de la invencion, se proporciona un antagonista de LFA que es un compuesto de Formula IIIB.
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Formula IA Formula IIA
Formula IIB
En algunos ejemplos, el antagonista de LFA-1 es un compuesto con una de las siguientes estructuras:
Claims (11)
- 5101520253035404550556065Reivindicaciones1. Un agente terapeutico que inhibe la interaccion de LFA-1 y una ICAM para su uso en el tratamiento de la retinopatfa diabetica, en el que el agente terapeutico tiene la formula IIB, o sus sales o esteres farmaceuticamente aceptables,
imagen1 Formula IIBAR1 es un resto arilo, heteroarilo, alquilarilo, alquilheteroarilo, alicfclico o heterocfclico monocfclico o policfclico; en la que R17 es hidrogeno, sales o esteres farmaceuticamente aceptables; y en la que R27 esimagen2 - 2. Un agente terapeutico para su uso de acuerdo con la reivindicacion 1 para el tratamiento del dano resultante de la retinopatfa diabetica seleccionado de edema macular, neovascularizacion de la retina, crecimiento fibrovascular sobre una retina, perdida de la vision, engrosamiento de la membrana basal, edema de retina o isquemia retiniana.
- 3. Un agente terapeutico para su uso de acuerdo con la reivindicacion 1, en el que dicha ICAM-1, ICAM-2 o ICAM-3, o en el que dicho agente terapeutico es un antagonista de LFA-1, preferentemente en el que dicho antagonista de LFA-1 se une a un sitio de union de alta afinidad en la subunidad aL de LFA-1 que se superpone al sitio de union de ICAM-1 o en el que dicho antagonista de LFA-1 es directamente competitivo con la union de ICAM-1 en la subunidad aL de LFA-1.
- 4. Un agente terapeutico para su uso de acuerdo con cualquiera de las reivindicaciones 1-3 de formula II.5101520253035404550556065
imagen3 Formula IIen la que R 27 es:imagen4 R28 es:imagen5 imagen6 y R29 es hidrogeno, una sal o ester farmaceuticamente aceptable, en el que los compuestos de Formula II comprenden estereoqufmica como en la Formula II',5101520253035404550556065imagen7 Formula II' - 5. Un agente terapeutico para su uso de acuerdo con la reivindicacion 1 de la formula:
imagen8 imagen9 5101520253035404550556065imagen10 S9imagen11 N5101520253035404550556065imagen12 o una sal o ester farmaceuticamente aceptable del mismo. - 6. Un agente terapeutico para su uso de acuerdo con la reivindicacion 1 de la formula
imagen13 - 7. Un agente terapeutico para su uso de acuerdo con cualquiera de las reivindicaciones 1-6, en el que dicho agente terapeutico se administra por via topica, oral, periocular, intraocular, mediante inyeccion, por via nasal, a traves de un aerosol, a traves de un inserto, a traves de un dispositivo implantado o mediante una gota; preferentemente, en el que dicho agente terapeutico se administra en un vehfculo portador que es gotas lfquidas, lfquido de lavado, lfquido nebulizado, gel, unguento, aerosol, pulverizacion, micropartfculas y nanopartfculas de polfmero, solucion, suspension, matriz solida biodegradable, polvo, cristales, o liposomas, opcionalmente, en el que dicho agente terapeutico se administra topicamente y dicha administracion topica comprende la infusion de dicho compuesto a dichos ojos a traves de un dispositivo seleccionado del grupo que consiste en un sistema de bomba-cateter, un inserto, un dispositivo de liberacion continua o selectiva, un implante bioabsorbible, una formulacion de liberacion continua o sostenida, y una lente de contacto; o, como alternativa, en el que dicho agente terapeutico se administra mediante inyeccion y dicha inyeccion se realiza por via intraocular, intravftrea, periocular, subcutanea, subconjuntival, retrobulbal o intracameral.
- 8. Un agente terapeutico para su uso de acuerdo con cualquiera de las reivindicaciones 1 - 6, en el que una cantidad terapeuticamente eficaz de dicho agente terapeutico se libera en el ojo a traves de liberacion local o sistemica, o en el que la administracion se logra administrando una instilacion intraocular de un gel, crema, polvo, espuma, cristales, liposomas, pulverizacion, micro o nanopartfculas polimericas o forma de suspension lfquida de dicho compuesto, preferentemente, en donde dicho compuesto se administra a dicho sujeto en una cantidad suficiente para alcanzar concentraciones intraoculares o retinianas desde 1 x 10-8 a 1 x 10-1 moles / litro.
- 9. Un agente terapeutico para su uso segun cualquiera de las reivindicaciones 1 - 6, en el que dicho compuesto se administra al menos una vez al ano, al menos una vez al dfa, al menos una vez por semana o al menos una vez al mes y, opcionalmente, en el que dicha administracion comprende ademas la etapa de determinar que dicho sujeto necesita tratamiento para la retinopatfa diabetica.
- 10. Un agente terapeutico para su uso de acuerdo con cualquiera de las reivindicaciones 1 - 6, que comprende ademas administrar un segundo agente terapeutico antes, en combinacion con, al mismo tiempo o despues de la administracion de dicho antagonista de LFA - 1, preferentemente, en el que el segundo agente terapeutico Se selecciona del grupo que consiste en antioxidantes, agentes antiinflamatorios, antimicrobianos, esteroides, inhibidores de la protefna quinasa C, inhibidores de la enzima convertidora de la angiotensina, agentes antiangiogenicos, inhibidores del complemento y agentes antiapoptoticos; opcionalmente, en el que el segundo agente terapeutico es un agente terapeutico antiadherente con un sitio de union competitivo alosterico sobre LFA-1, por ejemplo, en el que el segundo agente terapeutico es un anticuerpo terapeutico anti-adhesion o fragmento de anticuerpo.
- 11. Un agente terapeutico para su uso de acuerdo con cualquiera de las reivindicaciones 1 - 6, en el que la retinopatfa diabetica ha sido diagnosticada realizando una prueba diagnostica de retinopatfa diabetica sobre un sujeto y determinando si dicho sujeto sufre retinopatfa diabetica segun los resultados de dicha prueba diagnostica.
imagen14 imagen15 imagen16 imagen17 NHRCompuesto 1,R = (C=S)NH- Fluoresceina Compuesto 2A, R = HCompuesto 2B, R = (C=S)NH- FluorescemaCompuesto 4Compuesto 3Compuesto 5A-286982FIGURA 4+ - ++ + -Filtracion en gel + “ + - Compuesto 3 + + - -imagen18 abedimagen19 e f g hFIGURA 5(A) Compuesto 2Bimagen20 simulado wtCD11a MessCDUaimagen21 simulado wtCDUa MessCD11aFIGURA 6Absorbancia (450 nmj{A} LFA-1/1CAM-Hgimagen22 FIGURA 7CDCOELISA de L FA-1/m ole culaLog 1C3 50ELISA de LFA-1/molecula pequenaimagen23 OoFIGURAimagen24 imagen25 imagen26 imagen27 imagen28 FIGURA 11Farmacocinetica ocular en ratas30 Min4 Himagen29 trabecularimagen30 trabecular- ioo m
- MM w$m 1pM BLQ
[Concentracion del antagonista de LFA-1]FIG. 12
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-
2008
- 2008-10-17 US US12/288,330 patent/US20090155176A1/en not_active Abandoned
- 2008-10-17 JP JP2010529955A patent/JP5808037B2/ja active Active
- 2008-10-17 EP EP08842113.6A patent/EP2209371B1/en active Active
- 2008-10-17 EP EP16204718.7A patent/EP3167886B1/en active Active
- 2008-10-17 CA CA3105972A patent/CA3105972A1/en not_active Abandoned
- 2008-10-17 EP EP20189143.9A patent/EP3797775A1/en not_active Withdrawn
- 2008-10-17 CA CA2702984A patent/CA2702984C/en active Active
- 2008-10-17 CN CN200880117716A patent/CN101873797A/zh active Pending
- 2008-10-17 ES ES08842113.6T patent/ES2630406T3/es active Active
- 2008-10-17 CA CA2958665A patent/CA2958665C/en active Active
- 2008-10-17 WO PCT/US2008/011878 patent/WO2009054914A1/en active Application Filing
- 2008-10-17 AU AU2008317473A patent/AU2008317473B2/en active Active
- 2008-10-17 MX MX2010004281A patent/MX2010004281A/es active IP Right Grant
- 2008-10-17 ES ES16204718T patent/ES2830024T3/es active Active
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2014
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Also Published As
Publication number | Publication date |
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JP2011500683A (ja) | 2011-01-06 |
CN101873797A (zh) | 2010-10-27 |
US10960087B2 (en) | 2021-03-30 |
CA2958665C (en) | 2021-03-02 |
JP2014221808A (ja) | 2014-11-27 |
WO2009054914A1 (en) | 2009-04-30 |
US20210338839A1 (en) | 2021-11-04 |
CA2702984A1 (en) | 2009-04-30 |
AU2008317473A1 (en) | 2009-04-30 |
EP3797775A1 (en) | 2021-03-31 |
US20090155176A1 (en) | 2009-06-18 |
JP5808037B2 (ja) | 2015-11-10 |
CA2958665A1 (en) | 2009-04-30 |
US20160220702A1 (en) | 2016-08-04 |
ES2830024T3 (es) | 2021-06-02 |
EP3167886B1 (en) | 2020-08-05 |
EP2209371A1 (en) | 2010-07-28 |
AU2008317473B2 (en) | 2014-07-17 |
CA2702984C (en) | 2017-04-11 |
EP2209371B1 (en) | 2017-01-04 |
CA3105972A1 (en) | 2009-04-30 |
MX2010004281A (es) | 2010-09-10 |
EP2209371A4 (en) | 2011-11-02 |
EP3167886A1 (en) | 2017-05-17 |
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