Descripción del proyecto
Nueva nanomedicina contra el cáncer de páncreas
El cáncer de páncreas se considera uno de los tipos de cáncer más agresivos que existen, a lo que suma otro hecho agravante: a menudo, no es posible detectarlo en sus primeras fases debido a la falta de síntomas específicos. En virtud de todo ello, este tipo de cáncer se asocia a un mal pronóstico general, una baja tasa de supervivencia y unas opciones de tratamiento limitadas. Con el objetivo de ofrecer alternativas terapéuticas a los pacientes, el equipo del proyecto NoCanTher, financiado con fondos europeos, pretende desarrollar nanopartículas funcionalizadas con el fin de dirigirlas a las células del cáncer de páncreas y administrar así un antineoplásico en ese órgano. Los investigadores promoverán esta nanoformulación hasta la etapa de desarrollo clínico, lo que incluye el aumento de la producción en condiciones certificadas y la optimización de diversos parámetros para su uso en pacientes.
Objetivo
This project has been amended in July 2019 to better align the described tasks and timeline with the current status of the project.
The preceding Multifun Consortium (FP7 project Nº. 262943) has developed and validated distinct nanoformulations as therapeutic approach against pancreatic and breast cancer. These nanoformulations are based on magnetic iron oxide nanoparticles (MNP) multifuntionalised with a target peptide and an anticancer chemical drug, allowing for a synergistic therapeutic effect produced by the combination of intracellular drug delivery and magnetic hyperthermia. In particular, some of the designed formulations (patent filed PCT/EP2015/056631) have proven their efficacy, safety and non-toxicicty, in in vitro and in vivo studies, against the mentioned cancers, thus making them promising candidates to produce a novel nanomedicine therapy for cancer.
NoCanTher aims at translating one of these nanoformulations to early clinical development for pancreatic cancer. Particularly, we plan to assess bare nanoparticles (System B) and multifunctional nanoparticles (System A) in advanced preclinical models and run a clinical study with the System B. To successfully reach this objective, we will concentrate our efforts in two main group of activities:
• Nanotherapeutic up-scaling under Certfified conditions: NoCanTher will scale up the manufacturing of the proposed nanoformulation from milligram-scale laboratory synthesis up to multigram-scale production to generate sufficient material for clinical and regulatory assays. To this aim, a certified production line will be optimised and the relevant quality control will be conducted at the different stages of the up-scaling process.
• Clinical Study: NoCanTher will include late preclinical parameter testing to raise a clinical treatment protocol, regulatory assays, as well as the design of the clinical study and the preparation of the Investigational Medicinal Device Dossier (IMDD).
This strategy will allow us to apply for Clinical Study Authorisation (CSA) then, we will carry out a Clinical Study. NoCanTher involves the participation of 11 institutions from three different sectors (academia, industry, clinical) and from five different countries (Ireland, France, Germany, Spain and the UK).
Ámbito científico
- medical and health sciencesclinical medicineoncologyprostate cancer
- medical and health sciencesmedical biotechnologynanomedicine
- medical and health sciencesclinical medicineoncologybreast cancer
- engineering and technologynanotechnologynano-materials
- medical and health sciencesclinical medicineoncologypancreatic cancer
Palabras clave
Programa(s)
Convocatoria de propuestas
Consulte otros proyectos de esta convocatoriaConvocatoria de subcontratación
H2020-NMP-2015-two-stage
Régimen de financiación
RIA - Research and Innovation actionCoordinador
28049 Madrid
España