Queratitis neurotrófica:Datos preliminares del estudio REPARO presentados en el congreso de la ARVO

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Queratitis neurotrófica:Datos preliminares del estudio REPARO presentados en el congreso de la ARVO

– Queratitis neurotrófica:Datos preliminares del estudio REPARO presentados en el
congreso anual de la ARVO [Association for Research in Vision and Ophthalmology]. Este
estudio está diseñado para evaluar la seguridad y posible eficacia de rhNGF en el
tratamiento de esta enfermedad rara e incurable

– El factor de crecimiento nervioso humano recombinante (rhNGF), una
molécula de uso oftalmológico desarrollada por Dompé, es el primer tratamiento
potencial para la queratitis neurotrófica, una enfermedad para la que no existe un
tratamiento efectivo y afecta a menos de una de cada 5.000[1] personas.
– El rhNGF es la primera aplicación clínica de la investigación desarrollada
por Rita Levi Montalcini (ganadora del Premio Nobel de Medicina en 1986) sobre el
factor del crecimiento nervioso.
– Los resultados preliminares del estudio de fase I confirman la tolerabilidad
de rhNGF y muestran un alto porcentaje de pacientes que lograron una completa
curación de las lesiones de la córnea.
– El rhNGF está ahora en desarrollo de fase II y la reclutación de pacientes
está en marcha. El estudio se está llevando a cabo en 39 centros de 9 países
europeos.

Dompé, una compañía farmacéutica italiana, está creando nuevos prospectos para el
tratamiento de las úlceras de la córnea en pacientes afectados por la queratitis
neurotrófica, una condición ocular poco frecuente no curable que afecta a menos de una
de cada 5.000 personas en todo el mundo[1].

El rhNGF (el factor de crecimiento nervioso humano recombinante) está en desarrollo
clínico en el estudio REPARO, que se está realizando en 39 centros en 9 países
europeos. Los datos preliminares de la fase I del estudio, que implican a pacientes
afectados por la queratitis neurotrófica entre moderada y grave, se presentaron en el
congreso anual de ARVO (Orlando, EE. UU., 4-8 de mayo de 2014) y demostraron que el rhNGF
es bien tolerado.

El estudio examinó a 18 pacientes (7 hombres y 11 mujeres) que sufrieron queratitis
neurotrófica entre moderada o grave, resultado de la diabetes, infecciones oculares
causadas por el virus del herpes, intervenciones neuroquirúrgicas y otras enfermedades
relacionadas. Los pacientes reclutados en el estudio, que no respondieron a los
tratamientos médicos disponibles, se dividieron en cuatro grupos. En el primer grupo, los
pacientes recibieron una solución de gotas para el ojo de uso tópico a una dosis de 10
microg/ml. En el segundo grupo, se administró un vehículo simple. En el tercer grupo, se
administró una dosis de 20 microg/ml y, en el cuarto grupo, se administró placebo. Al
final del tratamiento, 11 pacientes tuvieron una mejora notable en las condiciones de la
córnea. Aunque los datos aún están «enmascarados» y, por tanto, aún no se sabe qué
pacientes recibieron rhNGF y cuáles recibieron el placebo, la resolución completa de las
lesiones corneales se registró en la mayoría de los pacientes, con porcentajes similares
en los dos grupos tratados con rhNGF a diferentes dosis, así como un aumento en la
sensibilidad de la córnea en aproximadamente uno de cada tres pacientes.

1. Sacchetti M., Lambiase A., Diagnosis and management of neurotrophic keratitis.
Clinical Ophthalmology 2014; 8: 571-579.

«Estos resultados son de gran importancia en el curso del desarrollo clínico de
rhNGF, un fármaco candidato que se origina desde la investigación desarrollada por la
ganadora del Premio Nobel, Rita Levi Montalcini,» explicó Eugenio Aringhieri, consejero
delegado del grupo Dompé. «Nuestros investigadores fueron los primeros en identificar una
molécula biotecnológica de NGF para uso oftalmológico. Los resultados de este estudio
destacan el potencial de NGF en el campo de la oftalmología. Dompé continuará siguiendo
su fuerte compromiso con los pacientes, centrando su I+D en áreas caracterizadas por
altas necesidades médicas no cubiertas, como la queratitis neurotrófica.»

«La queratitis neurotrófica se caracteriza por su gravedad y curso degenerativo,
resultante de la innervación reducida de la cornea como resultados de varios estados de
enfermedad (por ejemplo, diabetes, herpes, intervenciones quirúrgicas) que pueden incluso
conducir a consecuencias discapacitadoras, como la ulceración y perforación de la
córnea, que resulta en la pérdida de las funciones visuales», explicóel profesor
Stefano Bonini, jefe del Departamento de Oftalmología en el BioMedico Campus de Roma e
investigador jefe del estudio REPARO. «Hoy, tras años de estudio, estamos orgullosos de
poder argumentar nuestra investigación, que está también confirmada por los
prometedores resultados del estudio REPARO. Un resultado alentador que también ha venido
del sector industrial, mediante experiencia y visión, ha hecho posible producir un
fármaco bajo la evaluación clínica en un corto periodo de tiempo.»

La molécula está también en experimentación para el tratamiento del síndrome del
ojo seco y la retinitis pigmentosa.

Acerca de Dompé

http://www.dompe.com

Declaraciones prospectivas

Este comunicado podría contener declaraciones de futuro. Dompé cree de forma firme
que las expectativas reflejadas en las declaraciones de futuro son razonables y están
construidas sobre presunciones destacadas. A pesar de ello, debido a su naturaleza
importante, las declaraciones de futuro están sujetas a incertidumbres, incluyendo las
inherentes en el contexto de I+D y las asociadas a las decisiones realizadas por las
autoridades normativas. Así, Dompé no garantiza cumplimiento con los resultados
esperados respecto a lo mencionado anteriormente.

Dompe

CONTACT: CONTACTO Alessandro Aquilio Responsable de Asuntos Públicos y Comunicaciones Corporativas E-mail: alessandro.aquilio@dompe.it +39-02-58383-556 | +39-334-6550628

——-
Perfil: profile

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