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Un nuevo agente anti-cáncer desarrollado por Niiki Pharma demuestra prometedores resultados en fase I


News provided by

Niiki Pharma Inc.

01 Jun, 2011, 19:15 GMT

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HOBOKEN, Nueva Jersey y FILADELFIA, June 1, 2011 /PRNewswire/ --

- Un nuevo agente anti-cáncer, el primero de su clase, desarrollado por Niiki Pharma, demuestra prometedores resultados en fase I

- Los datos en fase I para NKP-1339, un agente anti-cáncer dirigido por transferrina primero en su clase, se presentarán en la próxima reunión anual de la American Society of Clinical Oncology

Niiki Pharma ha anunciado hoy que presentará sus datos interinos de un ensayo clínico en marcha en Fase I para su principal producto, NKP-1339, durante la reunión de la 2011 American Society for Clinical Oncology que se celebrará en Chicago, IL. NKP-1339 es un nuevo compuesto anti-cáncer destinado de transferrina basado en rutenio. Los objetivos intracelulares de NKP-1339 incluyen GRP78, un regulador clave del procesamiento de proteínas que se pliegan en una estructura poco habitual. En ensayos preclínicos, la actividad in vivo e in vitro se ha demostrado contra múltiples tipos de tumor, incluyendo los resistentes a otros agentes anti-cáncer.

El ensayo en fase I NKP-1339 es un ensayo de dosis ascendente y determina los datos de seguridad, tolerabilidad, dosis máxima tolerada (MTD) y también farmacocinética de NKP-1339. Hasta la fecha han sido tratados 16 pacientes con tumores sólidos metastásicos resistentes a las terapias estándares en seis niveles de dosis diferentes. El tratamiento con NKP-1339 generalmente se ha tolerado de forma correcta, y los efectos secundarios más habituales han sido fiebre de grado 1-2 y síntomas leves similares a la gripe. No se ha alcanzado la MTD y sigue la escalada de dosis de NKP-1339. Se han observado signos de actividad antitumoral (enfermedad estable superior que o igual a cuatro meses; regresión del tumor). Un paciente con tumor neuroendocrino (NET) del intestino delgado se ha mantenido dentro de la terapia basada en NKP-1339 durante más de 13 meses con una respuesta menor continuada. El paciente sigue estando dentro de la terapia basada en NKP-1339. Otro paciente con gastrinoma metastásico NET ha mostrado la estabilidad de la enfermedad a los seis meses, y dos pacientes con cáncer de células pulmonares metastásicas no pequeñas ha mostrado a los cuatro meses una enfermedad estable.

El ensayo en fase I NKP-1339 está dirigido por el doctor Daniel Von Hoff, del Translational Genomics Institute de Arizona, y por el doctor Howard Burris, del Sarah Canon Research Institute de Tennessee. Reflejando el nuevo mecanismo de acción de NKP-1339, el doctor Von Hoff comentó: "La resistencia a la terapia anti-cáncer sigue siendo un reto importante para el tratamiento de los pacientes con cáncer metastático. Los fármacos de primera clase, como NKP-1339, nos pueden llevar un paso más allá para conseguir esta gran necesidad no cumplida". Por su parte, el doctor Burris indicó: "Los resultados conseguidos hasta la fecha indican que NKP-1339 podría ser un nuevo agente prometedor que mejoraría nuestro armamento anti-cáncer".

Acerca de Niiki Pharma

Niiki Pharma Inc. es una compañía de desarrollo de productos oncológicos terapéuticos con una fama de nuevos agentes destinados contra el cáncer. Si desea más información visite la página web http://www.niikipharma.com.

Acerca del Translational Genomics Institute

El Translational Genomics Research Institute (TGen) se dedica a realizar investigaciones revolucionarias con enfermedades como el cáncer, enfermedades neurológicas y la diabetes. Si desea más información visite http://www.tgen.org

Acerca del Sarah Cannon Research Institute

El Sarah Cannon Research Institute (SCRI) es una organización de investigación clínica mundial centrada en el avance de terapias y aceleración de desarrollo de fármacos en áreas como la oncología, cardiología y gastroenterología. Si desea más información visite http://sarahcannonresearch.com.

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