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Nanomedicine upscaling for early clinical phases of multimodal cancer therapy

Nanomedicine upscaling for early clinical phases of multimodal cancer therapy

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During the last four years the 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. To successfully reach this objective, we will concentrate our efforts in two main group of activities:
• Nanomedicine up-scaling under GMP 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 GMP production line will be optimised and the relevant quality control will be conducted at the different stages of the up-scaling process.
• Clinical trial: NoCanTher will include late preclinical parameter testing to raise a clinical treatment protocol, regulatory assays, as well as the design of the clinical trial and the preparation of the Investigational Medicinal Product Dossier (IMPD).

This strategy will allow us to apply for Clinical Trial Authorisation (CTA) then, we will carry out a Phase I clinical trial.
NoCanTher involves the participation of institutions from three different sectors (academia, industry, clinical) and from five different countries (Ireland, France, Germany, Spain and the UK).

Koordinator

FUNDACION IMDEA NANOCIENCIA

Adresse

Ciudad Universitaria De Cantoblanco - Calle Faraday 9
28049 Madrid

Spanien

Aktivitätstyp

Higher or Secondary Education Establishments

EU-Beitrag

€ 665 000

Beteiligte (11)

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BIOPRAXIS RESEARCH AIE

Spanien

EU-Beitrag

€ 1 302 240

IMMUPHARMA PLC

Vereinigtes Königreich

EU-Beitrag

€ 427 820

CHEMICELL GMBH

Deutschland

EU-Beitrag

€ 400 000

FUNDACION CENTRO NACIONAL DE INVESTIGACIONES ONCOLOGICAS CARLOS III

Spanien

EU-Beitrag

€ 88 538,36

Universitätsklinikum Jena

Deutschland

EU-Beitrag

€ 765 125

RESONANT CIRCUITS LIMITED

Vereinigtes Königreich

EU-Beitrag

€ 700 000

FUNDACIO HOSPITAL UNIVERSITARI VALL D'HEBRON - INSTITUT DE RECERCA

Spanien

EU-Beitrag

€ 549 441,25

THE PROVOST, FELLOWS, FOUNDATION SCHOLARS & THE OTHER MEMBERS OF BOARD OF THE COLLEGE OF THE HOLY & UNDIVIDED TRINITY OF QUEEN ELIZABETH NEAR DUBLIN

Irland

EU-Beitrag

€ 691 847,50

UNIVERSITE PARIS DIDEROT - PARIS 7

Frankreich

EU-Beitrag

€ 611 000

FUNDACIO PRIVADA INSTITUT D'INVESTIGACIO ONCOLOGICA DE VALL-HEBRON

Spanien

EU-Beitrag

€ 352 287,50

HOSPITAL UNIVERSITARIO DE FUENLABRADA

Spanien

EU-Beitrag

€ 560 479,14

Projektinformationen

ID Finanzhilfevereinbarung: 685795

Status

Laufendes Projekt

  • Startdatum

    1 April 2016

  • Enddatum

    31 März 2021

Finanziert unter:

H2020-EU.2.1.2.

  • Gesamtbudget:

    € 7 113 778,75

  • EU-Beitrag

    € 7 113 778,75

Koordiniert durch:

FUNDACION IMDEA NANOCIENCIA

Spanien