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Berlin, Germany

Agency: Cordis | Branch: FP7 | Program: CP-IP | Phase: NMP.2012.1.2-2 | Award Amount: 12.84M | Year: 2013

NanoAthero aims to have demonstration of 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 from academia, a European association, SMEs and a large pharmaceutical company. 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. In NanoAthero, the nanocarriers carrying compounds to visualize thrombus or vulnerable plaques, or to deliver therapeutic agents should be suitable for proof-of-concept in patients. Phase I clinical trials targeting pivotal pathways in atherothrombosis will be performed with nanosystems for diagnosis and treatment of carotid atheroma. NanoAthero aims to propose nanosystems for thrombus imaging, stroke treatment and plaque stabilization in high-risk patients. Molecular imaging and therapeutic treatments in NanoAthero are based on feasible approaches.

Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2011.1.4-3 | Award Amount: 7.73M | Year: 2012

DARTRIX, DARPin Targeted RX (therapy) is a multidisciplinary collaborative project that will develop high-affinity protein scaffolds to create a new generation of targeted therapeutics for the treatment of glioblastoma. There is great need; glioblastoma is virtually incurable and most patients die within 12 months of diagnosis. DARPins are small, non-immunoglobulin human protein scaffolds that bind specific targets with exceptionally high-affinity. DARPins are amenable to GMP production and to scale-up. They are remarkably stable, even at high temperatures and they can be engineered to incorporate additional favourable properties to target glioblastoma cells with exceptionally high affinity. The new DARPins will be coupled to dextran-coated iron oxide nanoparticles, such as ferucarbotran or nanomag-MIP, which has been used clinically as a contrast agent for Magnetic Resonance Imaging (MRI). These particles are safe to use in patients and are traceable within the body. When stimulated by an appropriate alternating magnetic current, the particles generate heat that can kill cancer cells very effectively. The conjugation of DARPins with ferucarbotran or nanomag-MIP (DARTRIX particle) leads to a potent therapeutic by delivering targeted hyperthermia to glioblastoma. In addition, DARTRIX particle will be created economically, exploiting the fact that DARPins can be produced to GMP in gram quantities using E. coli. The DARTRIX particles will target to glioblastoma cells by virtue of the high affinity and specificity of DARPins and the particles will remain in place when heated. By using DARPins to target the DARTRIX particle to tumour cells before application of the magnetic current, it should be possible to generate toxic heat specifically in the tumour. The consortium has all the skills and knowledge to develop DARPins from bench-to-bedside for glioblastoma treatment. This DARTRIX particle will pioneer targeted hyperthermic cancer treatment of glioblastoma in an innovative adaptive first-in-man trial, using direct injection or convection enhanced delivery to localise the particles to the tumour.

Agency: Cordis | Branch: FP7 | Program: CP-IP | Phase: HEALTH-2009-1.4-2 | Award Amount: 15.57M | Year: 2010

The goal of VascuBone is to develop a tool box for bone regeneration, which on one hand fulfils basic requirements and on the other hand is freely combinable with what is needed in the respective patients situation. The tool box will include a variation of biocompatible biomaterials and cell types, FDA approved growth factors, material modification technologies, simulation and analytical tools like molecular imaging based in vivo diagnostics which can be combined for the specific medical need. This tool box will be used to develop translational approaches for regenerative therapies of three different types of bone defects. The chosen bone diseases differ in their requirements, to ensure a successful implementation and translation. Additionally this implementation strategy is characterized by high complexity to remove bottlenecks and limitations of bone regeneration identified in the clinical setting. Therefore definite quality criteria have to be evaluated concerning an optimal stem cell source/subpopulation as well as GF concentrations and their bioactivity in vivo. Furthermore quantitative evaluation will focus on the definition of differences between stem cell populations responsible for bone regeneration in young and old people, as a prerequisite for the development of regenerative therapies for the ageing European society. Considering a successful and prompt approval of the biomaterial, for each clinical application a minimum of modification steps in daily routine must be identified. The road map of the project and clinic trials contains pre-determined milestones, to ensure efficacy, safety, and immunological acceptance of the implant. The efficacy is quantified by high innovative MRI and PET/CT technology which is able to demonstrate the regenerative effect of biomaterials and cells in vivo. Based on the clinical data the proposal as Advanced Therapeutical Medicinal Product will be submitted to the European Medicines Agency at the end of the project.

Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: NMP-2009-1.1-1 | Award Amount: 2.62M | Year: 2011

Nanoscience and nanotechnology are currently revolutionizing sectors such as medicine, information technologies, environmental or materials sciences, and creating new opportunities for our societies. In this context, magnetic nanoparticles (MNP) are key components to the development of novel nano- and biotechnologies. Magnetosomes are unique hybrid magnetic MNP produced by magnetotactic bacteria (MB). They are employed in applications ranging from extraction of DNA to the development of immunoassays and uses in spintronics are envisaged. However, only a very limited amount of MNP (few mg per day) can be formed by MB, and the formation principles remain to be tackled. Biomimetics, i.e. combining biological principles with chemistry, will pave the way to understand biomineralization of tailored MNP and to find out high-value high-yield synthetic routes to solve scientific and technological challenges. Specifically, we aspire at bridging the gap between different fields of science. For the first time, we will blend biological and genetic approaches with chemical and physical knowledge to understand the key parameters controlling the size, shape, composition and assembly of hybrid MNP in vivo and in vitro. We will combine nanoscience and nanotechnology to modify these properties and develop an ensemble of magnetic nanomaterials of higher values. This approach will lead to original contributions of innovative nature based on the combined skills of the partners to manufacture and characterize the biological, chemical, structural and magnetic properties of the MNP. The industrial partner will have key importance in managing and assessing the applicability of the MNP in Magnetic Resonance Imaging (MRI). Finally, our cell biologist partner will test the biocompatibility of the designed systems. In 3 years, we aim at being able to synthesize hybrid MNP with tailored magnetic and size properties by low-cost high-yield synthesis for applications in MRI.

Agency: Cordis | Branch: FP7 | Program: CP-IP | Phase: NMP.2013.1.4-2 | Award Amount: 11.56M | Year: 2013

The NanoMag project is to improve and redefine existing analyzing methods and in some cases, to develop new analyzing methods for magnetic nanostructures. Using improved manufacturing technologies we will synthesize magnetic nanoparticles with specific properties that will be analyzed with a multitude of characterization techniques (focusing on both structural as well as magnetic properties) and bring the experimental results together to obtain a self-consistent picture which describes how structural and magnetic properties are interrelated. This extensive survey will be used to define standard measurements and techniques which are necessary for defining a magnetic nanostructure and quality control. NanoMag brings together Europes and internationally leading experts in; manufacturing of magnetic single-core nanoparticles and magnetic multi-core particles, analyzing and characterization of magnetic nanostructures and national metrology institutes. In the consortium we have gathered partners within research institutes, universities and metrology institutes, all carrying out front end research and developing applications in the field of magnetic nanoparticles.

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