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PharmaMar anuncia que la Agencia Española de Medicamentos y Productos Sanitarios ha autorizado el ensayo clínico APLICOV-PC con Aplidin® (plitidepsina) para el tratamiento de pacientes con COVID-19
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- El objetivo del ensayo es evaluar la eficacia y la seguridad de la plitidepsina en pacientes con COVID-19 que requieren ingreso en el hospital

- La plitidepsina obtuvo recientemente resultados positivos en estudios in vitro del coronavirus humano HCoV-229E, realizados en el Centro Nacional de Biotecnología del Consejo Superior de Investigaciones Científicas (CSIC) de España

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Apr 28, 2020, 11:14 ET

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MADRID, 28 de abril de 2020 /PRNewswire/ -- PharmaMar (MSE: PHM) ha anunciado el inicio del ensayo clínico APLICOV-PC con Aplidin® (plitidepsina), para el tratamiento de pacientes con COVID-19, el cual ha sido autorizado por la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS).

Se trata de un estudio multicéntrico, aleatorizado, paralelo y abierto para evaluar el perfil de seguridad y la eficacia de tres dosis de plitidepsina en pacientes con COVID-19 que requieren ingreso hospitalario.

Tres hospitales de Madrid (España) participarán en el estudio. Tres cohortes de pacientes con tres niveles diferentes de dosis se incluirán en el estudio para evaluar la eficacia y la seguridad de la plitidepsina en cada nivel de dosis administrada a pacientes ingresados en hospitales con COVID-19.

En esta primera etapa, participarán 27 pacientes, a los cuales se administrarán tres dosis. Se medirá la carga viral de los pacientes antes y después del tratamiento, así como una serie de otros parámetros para evolución clínica. Si los resultados fueran positivos en esta etapa inicial, el ensayo continuaría con la dosis óptima, después de hablar con el regulador, con una cohorte más amplia de pacientes.

El 13 de marzo, la Compañía anunció los resultados de estudios in vitro de plitidepsina en el coronavirus humano HCoV-229E, que tiene un mecanismo de multiplicación y propagación muy similar al SARS-CoV-2, ya que ambos usan la proteína eEF1A para su reproducción. Los estudios se llevaron a cabo en el Centro Nacional de Biotecnología del Consejo Superior de Investigaciones Científicas (CSIC) de España (ver comunicado de prensa).

La plitidepsina actúa bloqueando la proteína eEF1A, presente en células humanas, que es utilizada por el SARS-CoV-2 para reproducirse e infectar otras células. Mediante esta inhibición, la expectativa es que se evite la reproducción del virus dentro de la célula, haciendo inviable esta propagación al resto de las células.

Aviso legal 

Este comunicado de prensa no constituye una oferta para vender ni una solicitud de una oferta para comprar valores, y no constituirá una oferta, solicitud o venta en ninguna jurisdicción en la que dicha oferta, solicitud o venta sería ilegal antes del registro o la verificación bajo las leyes de valores de esa jurisdicción.

Acerca de PharmaMar

PharmaMar es una empresa biofarmacéutica con sede en Madrid, centrada en oncología y comprometida con la investigación y desarrollo (I+D) que se inspira en el mar para el descubrimiento de moléculas con actividad antitumoral. Es una empresa que busca productos innovadores para dotar de nuevas herramientas a los profesionales de la salud para tratar el cáncer. Su compromiso con los pacientes y con la investigación la ha convertido en uno de los líderes mundiales en el descubrimiento de medicamentos antitumorales de origen marino.

PharmaMar tiene una cartera de posibles medicamentos nuevos y un robusto programa oncológico de I+D. La empresa desarrolla y comercializa Yondelis® en Europa y tiene otros programas en fase clínica en desarrollo para diversos tipos de cánceres sólidos: lurbinectedina (PM1183), PM184 y PM14. PharmaMar tiene subsidiarias en Alemania, Italia, Francia, Suiza, Bélgica, Austria y los Estados Unidos, y la propiedad total de otras empresas: GENOMICA, una empresa de diagnóstico molecular, y Sylentis, dedicada a la investigación de aplicaciones terapéuticas del silenciamiento génico (RNAi). Para más información sobre PharmaMar, visítenos en www.pharmamar.com.

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FUENTE PharmaMar

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