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Menarini Ricerche anuncia los resultados del ensayo clínico de MEN1611
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Sep 17, 2020, 10:00 ET

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- Menarini Ricerche anuncia los resultados de la fase de escalada de dosis del ensayo clínico de MEN1611 en cáncer de mama

Hallazgos del estudio B-PRECISE-01 presentados en el Congreso Virtual ESMO 2020

POMEZIA, Italia, 17 de septiembre de 2020 /PRNewswire/ -- Menarini Ricerche, la división de I+D de Menarini Group, ha anunciado hoy los resultados  de la fase  de escalada de dosis de su ensayo clínico B-PRECISE-01(NCT03767335) que está evaluando MEN1611, un potente y selectivo inhibidor de fosfatidilinositol 3-kinasa (PI3K) en desarrollo para el tratamiento del cáncer de mama.

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B-PRECISE-01 trial Logo
B-PRECISE-01 trial Logo

El poster titulado "Results of the phase 1b dose escalation study of MEN1611, a PI3K Inhibitor, combined with trastuzumab (T) ± fulvestrant (F) for HER2+/PIK3CA mutant (mut) advanced or metastatic (a/m) breast cancer (BC)" (ID number: 347P) se presentará en el Congreso Anual  de la Sociedad Europea de Oncología Médica (ESMO), que tendrá lugar de forma virtual del 19 al 21 de setiembre de 2020. 

B-PRECISE-01 es un estudio abierto, multicéntrico de fase Ib, de dosis y expansión de cohortes, realizado en pacientes con cáncer de mama avanzado o metastásico, HER2-positivo, PIK3CA mutado, en progresión  tras  al menos dos líneas de terapia anti-HER2. El estudio tiene como objetivos principales determinar la seguridad e identificar  la dosis de fase 2 recomendada (RP2D) de MEN1611 en combinación con trastuzumab +/- fulvestrant. Los objetivos secundarios son la evaluación de la actividad clínica preliminar, la farmacocinética y la farmacodinámica del producto en investigación.  

La combinación de MEN1611 + trastuzumab +/- fulvestrant ha mostrado un aceptable perfil de tolerabilidad sin  toxicidad dosis-limitante durante la fase de escalada y la mayoría de los acontecimientos  adversos relacionados con la administración de MEN1611  tratamiento fueron reversibles y respondieron bien al tratamiento sintomático. La RP2D se estableció en 48 mg en 2 administraciones diarias.  La prometedora actividad antitumoral en pacientes fuertemente pretratados, junto con el prolongado control de la enfermedad ejustifica  el paso a la  fase de expansión de cohortes del estudio B-PRECISE-01, con la finalidad de evaluar   la RP2D en pacientes con cáncer de mama de HER2-positiva, PIK3CA mutado, avanzado o metastásico.

Acerca de Menarini

Menarini Ricerche es la división de Grupo Menarini Internacional dedicada a la I+D con un fuerte compromiso con la investigación y el desarrollo oncológicos, así como una implicación activa en el campo de las enfermedades infecciosasy la lucha contra la resistencia antimicrobiana, una creciente preocupación global.

Como parte de este compromiso con la oncología, Menarini tiene en cartera cinco nuevos fármacos de investigación para el tratamiento de una variedad de tumores hematológicos y/o sólidos. Dos de ellos son biológicos, uno es el anticuerpo monoclonal anti-CD157 MEN1112/OBT357, y el otro es un anticuerpo de toxina conjugada anti-CD205 MEN1309/OBT076. Otros tres son pequeñas moléculas, como el inhibidor de quinasa dual PIM y FLT3 SEL24/MEN1703, y el inhibidor PI3K MEN1611, y el inhibidor de la clase I, II y IV histona deacetilasa, Pracinostat.

La adquisición de Stemline Therapeutics Inc., una compañía biofarmacéutica con sede en Nueva York, ha reforzado la cartera de oncología de Menarini con la incorporación de activos comerciales y de fase clínica, como ELZONRIS®, una nueva terapia objetiva para el tratamiento de neoplasia de célula dendrítica plasmacitoide blástica  (BPDCN). Menarini también ha entrado en un acuerdo de licencia con Radius Health para el desarrollo y comercialización de Elacestrant, un SERD oral en desarrollo de fase 3 de fase tardía como tratamiento hormonal para el cáncer de mama. Mediante el trabajo de Menarini Silicon Biosystems, Menarini también está desarrollando tecnologías y productos avanzados para estudiar células raras con precisión unicelular. 

Grupo Menarini Internacional es una compañía farmacéutica y de diagnóstico líder, con unos ingresos de 3.793 millones de euros y más de 17.000 personas empeadas. Menarini se encuentra en las áreas terapéuticas más importantes con productos para cardiología, gastroenterología, neumología, enfermedades infecciosas, diabetología, inflamación y analgesia. Con 16 plantas de producción y 10 centros de investigación y desarrollo, los productos de Menarini están disponibles en 140 países en todo el mundo. Para más información, visite www.menarini.com

Logo: https://mma.prnewswire.com/media/1199083/Menarini_Ricerche_Logo.jpg 
Logo: https://mma.prnewswire.com/media/1274653/B_Precise_01_trial_Logo.jpg

Related Links

http://www.menarini.com/

SOURCE Menarini Ricerche

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