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Nanomedicine for target-specific imaging and treatment of atherothrombosis : development and initial clinical feasibility

Abstract
NanoAthero is a European-funded project under the 7th Framework Programme for Research. The main objective of this project is to address more in depth prospects of improved diagnosis and treatment of atherosclerosis by means of nanotechnology.

Facts & Figures
- Total project volume: EUR 12.8 million
- Project time: five years (1026 person-months)
- Start of the project: 1 February 2013
- 16 partners from 10 countries

Objectives:

NanoAthero aims to demonstrate initial clinical feasibility of nanosystems for targeted imaging and treatment of advanced atherosclerotic disease in humans. The nanosystems are assemblies of following components: nanocarrier, targeting, imaging agent/drug. They have proven safety records, and strong preliminary in vitro and in vivo proofs of efficacy are available. Partners have patented and provided evidence of efficacy of carriers and ligands.
Over 5 years, NanoAthero will integrate GMP production, the initiation of clinical investigations in high-risk patients, including the preparation of regulatory dossiers, risk and ethical assessments, and the evaluation of the performance of optimized diagnostic and therapeutic compounds. NanoAthero offers a unique opportunity for combining in-depth knowledge of nanocarrier bioengineering and production with state-of the art expertise in imaging and treatment of cardiovascular patients providing a full bench-to-bedside framework within one collaborative consortium of 16 partners.
NanoAthero gathers together leading chemists, engineers, pharmacists, biologists, toxicologists, clinicians, analysts, ethicists and key-opinion leaders in the field of cardiovascular medicine and early drug development, a European association, 3 SMEs and a large pharmaceutical company (i.e.Bracco).
Phase I clinical trials targeting pivotal pathways in atherothrombosis will be performed with nanosystems for diagnosis and treatment of carotid atheroma and stroke. NanoAthero aims to complete phase I evaluation of two nanosystems: thrombus imaging and plaque stabilization in high-risk patients. Preclinical studies for two nanosystems (one to dissolve blood clots in stroke and one for plaque imaging) will be collaboratively completed and collection of clinical data will be launched.

Keywords
medical diagnostics
Molecular pathology
electrical and biomedical technics
magnetic resonance tomography
circulatory diseases
laboratory diagnostics
Biotechnology
Atherosklerose
Diagnostik
Nanotechnologie
Therapie
Local Subprojectlead:
Mangge Harald
Duration:
01.02.2013-31.01.2018
Programme:
EU (FP-7)
Subprogramme
NMP.2012.1.2-2: Development and phase-I clinical trials of novel therapeutic nanotechnology-enabled systems for the diagnosis and treatment of atherosclerosis.
EU-Project Instruments
Collaborative Project (Large-Scale Integrating Project)
Type of Research
applied research
Staff
Mangge, Harald, Project Leader
Pailer, Sabine, Co-worker
Almer, Gunter, Co-worker
Opriessnig, Peter, Co-worker
MUG Research Units
Clinical Institute of Medical and Chemical Laboratory Diagnostics
Project partners
Assistance Publique - Hopitaux de Paris, France
Bracco Imaging SpA, Italy
Commissariat a l´Energie Atomique et aux Energies Alternatives, France
Edinethics, United Kingdom
INSERM, France
Inserm-Transfert, France
Max-Planck-Society, Germany
NanoPET Pharma, Germany
Odense University Hospital, Denmark
Semmelweis University Budapest, Hungary
University of Erlangen, Germany
University of Twente, Netherlands
WizSoft, Israel
, Netherlands
Funded by
Europäische Kommission, Rue de la Loi, Brussels, Belgium
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