Data-Gouv-ML/pcri-informations-sur-les-projets-laureats huggingface dataset:
Clinical safety, immunogenicity and efficacy of a therapeutic vaccine that combines peptides mimicking antigen receptors on autoimmune B and T cells associated with myasthenia gravis (MYASTERIX)

Framework: FP7 — Cooperation
Programme: Health
Destination: Biotechnology, generic tools and medical technologies for human health
Action type: Collaborative project
Countries involved: France,Netherlands,Belgium,Austria
Call:  (FP7-HEALTH-2013-INNOVATION-1, 2013)
Start date: 2013-10-01
End date: 2018-09-30
Duration (months): 60.0
Total project cost (EUR): 7374398.56
EU funding (EUR): 5900720.0
Participants: 6
Project status: CLOSED

The MYASTERIX project will advance a therapeutic vaccine candidate (designated orphan drug) indicated for the autoimmune disease myasthenia gravis (MG) to clinical proof of concept studies. MG is caused by T cell dependent antibodies that bind to and deplete acetylcholine receptors (AChR) at neuromuscular junctions causing muscle weakness by interfering with neuromuscular transmission and junction architecture. The vaccine candidate comprises two synthetic peptides designed to generate antibodies that bind to autoantibodies and T-cell receptors associated with MG. These peptides prevented or improved muscle fatigue in a rat model of MG and increased the remission rate to 75% in pet dogs (compared to 17% natural remission rate in historical controls). In both models, administration of the peptides resulted in reduced titres of anti-AChR antibodies and lower numbers of anti-AChR T-cells, based on the induction of antibodies that bound to the corresponding B and T cell antigen receptors. These results suggest that similar antigen receptor mimetic vaccination approaches could drive autoimmune diseases like MG into long-term remission. The objectives of the project are to manufacture toxicology and clinical batches of the vaccine human formulation based on already developed and tested standard operating procedures, to carry out stability and regulatory toxicity testing of the GMP product, to conduct phase I and subsequently phase II clinical trials to demonstrate safety, tolerability and proof of mechanism of action/concept of the therapeutic vaccine. The impact on MG patients will be to offer a targeted therapeutic approach requiring only three injections, bringing significant and lasting improvement or even a cure. MG is a model for many autoimmune diseases and the concept of targeted therapeutic vaccines could lead to a new class of drugs for the treatment of autoimmune diseases more generally, with a significant impact on innovation, competitiveness and society.

Keywords: myasthenia,myasthenie,therapeutic vaccine,clinical trial,anti-idiotypic,orphan drug,acetylcholine receptor,achr
Development of a universal influenza vaccine based on tandem core technology (FLUTCORE)

Framework: FP7 — Cooperation
Programme: Health
Destination: Translating research for human health
Action type: Collaborative project
Countries involved: United Kingdom,United Kingdom,Latvia,Luxembourg,Spain,Spain
Call:  (FP7-HEALTH-2013-INNOVATION-1, 2013)
Start date: 2013-09-01
End date: 2017-03-31
Duration (months): 43.0
Total project cost (EUR): 4142177.04
EU funding (EUR): 3162303.66
Participants: 7
Project status: CLOSED

FLUTCORE will develop a novel universal influenza A virus (IAV) vaccine based on the tandem core vaccine platform. Recent influenza pandemics have emphasized the urgent need for better vaccines that are reactive with multiple IAV subtypes and that are no longer dependent on intimate knowledge of the prevalent virus. We propose to replace the existing seasonal IAV vaccine with a virus like particle (VLP) carrying several invariant “universal” influenza antigens. Previous attempts to use these targets have failed due to the poor antigen expression and immunogenicity. The highly immunogenic tandem core system overcomes this limitation. Specifically, we propose to develop a VLP carrying two or more invariant influenza antigens, express these in yeast and then examine immunogenicity in mice. The vaccine will be further tested in the rigorous ferret system before being scaled up for manufacture. An optimal clone will then be transferred to an accredited contract manufacturer for production. A phase I clinical trial will be carried out once pre-clinical toxicology has been successfully completed. Our consortium will examine the immune responses in both animals and humans thoroughly to ensure that the vaccine candidate chosen can produce a protective IAV immune response in all individuals. To achieve these objectives, our proposal builds upon the complementary expertise of seven high-performing partners representing four European countries, with world leadership in HBV core biology, immunological analysis, commercial manufacture and influenza clinical trials, making our consortium ideally positioned to develop the vaccine and to take it from bench to bedside. The leading role of SMEs in the consortium will ensure that the technology developed by FLUTCORE will generate highly marketable products, offering both improved patient protection and long-term cost savings for health care in Europe once annual influenza vaccines are replaced.

Keywords: influenza,vaccine,universal,vlp
Clonidine for Sedation of Paediatric Patients in the Intensive Care Unit (CLOSED)

Framework: FP7 — Cooperation
Programme: Health
Destination: Other Actions across the Health Theme
Action type: Collaborative project
Countries involved: Germany,United Kingdom,Netherlands,Italy,Sweden,Estonia,Czechia,Netherlands,United Kingdom
Call:  (FP7-HEALTH-2013-INNOVATION-1, 2013)
Start date: 2013-12-01
End date: 2018-11-30
Duration (months): 60.0
Total project cost (EUR): 7498976.47
EU funding (EUR): 5997404.75
Participants: 12
Project status: CLOSED

The majority of critically ill children admitted to Paediatric Intensive Care Units (PICU) will require sedation and analgesia which is commonly achieved with a combination of an benzodiazepine and an opioid. However, these agents have a significant side-effect profile, including tolerance, withdrawal and respiratory/circulatory depression. Clonidine is commonly used for sedation in PICU and recommended by guidelines in various countries although there is a lack of evidence regarding it safety and efficacy in this setting. The need for safety and efficacy data as well as an age appropriate formulation for clonidine has been realised and clonidine is included in the EMA “Revised Priority List for Studies into Off-patent Medicinal Products”. Thus this proposal addresses an important paediatric therapeutic need. It is designed to fullfill the requirements for most ethical research in the paediatric population considering risk minimisation for patients, avoiding unnecessary studies and make use of already available data as outlined in the Paediatric Regulation (EC) No 1901/2006. The objectives of this project are a) to develop an age appropriate formulation of clonidine suitable for sedation of children in PICU b) to conduct a randomised, phase III, double-blind, active-controlled parallel group clinical trial of clonidine vs midazolam in patients from birth to 18 years to establish the efficacy and safety, including long-term outcomes and dose-dependent effects of clonidine and c) to establish an European consensus guideline for sedion of critically ill children. The ultimate goal is to use these data and to apply for a PUMA. On this basis a Paediatric Investigation Plan (PIP) has been approved by the EMA in February 2013 and is reflected in the work plan of CloSed. The project will increase the availability of paediatric medicines, foster the conduct of clinical trials in children and establish international paediatric research collaborations.

Keywords: clonidine,sedation,paediatric,children,neonates,paediatric intensive care,iv formulation,off-patent medicines
Proposal to assess an innovative Immunotherapy, based on a thioredox peptide antigen, in a Phase I Trial for Type-1 Diabetes (EXALT)

Framework: FP7 — Cooperation
Programme: Health
Destination: Biotechnology, generic tools and medical technologies for human health
Action type: Collaborative project
Countries involved: France,Belgium,Belgium,Germany,United Kingdom
Call:  (FP7-HEALTH-2013-INNOVATION-1, 2013)
Start date: 2014-02-01
End date: 2019-01-31
Duration (months): 60.0
Total project cost (EUR): 13076048.57
EU funding (EUR): 6000000.0
Participants: 6
Project status: CLOSED

Type-1 diabetes (T1D) is an autoimmune disease in which pancreatic β-cells are gradually destroyed by autoreactive T-cells recognising autoantigens (Auto-Ag) such as GAD65 and insulin. ImCyse, a small SME, has developed a new technology based on short synthetic peptides flanked with a thioredox motif, which silence the pathogenic immune response against several auto-Ag through activation of one auto-Ag specific cytolytic CD4+ T-cells (cCD4). Preclinical work carried out by ImCyse with such peptides in a specific T1D mouse model showed that insulitis, an absolute condition for the development of T1D, is fully prevented (and/or suppressed) upon either active immunisation or passive transfer of GAD65-specific cCD4+ T cells. This was also observed for the prevention of hyperglycaemia. The overall objective of the project is to perform a Phase I clinical study in adult T1D patients, using an immunotherapeutic (ITx) preparation based on the ImCyse technology. Primary objectives are to obtain safety data and information on the immune response, in particular the induction of cCD4+ T-cells and autoimmune responses. Clinical responses will also be monitored. A five-member expert international consortium will conduct: co-ordination, ITx optimisation & GMP process development, manufacturing, toxicity evaluation, regulatory filing, preparation and conduct of the clinical trial and exploitation/dissemination of results. The expectation is to exploit this antigen-specific immune modulation by immunising T1D patients in order to halt disease progression, and also to validate this new technology that could in the long term be applied to other autoimmune diseases. In addition, this project would benefit: patients (better quality of life), the European economy (decreased cost of the disease), science (mechanistic insight), employment (conduct of further trials in Phase II and III) and the synergistic contribution of different partners (SME/industry/public).

Keywords: type-1 diabetes,autoimmune disease,immunotherapeutic,antigen-specific immune regulation,cytolytic cd4 t-cells,synthetic modified peptide.
Development and Epilepsy - Strategies for Innovative Research to improve diagnosis, prevention and treatment in children with difficult to treat Epilepsy (DESIRE)

Framework: FP7 — Cooperation
Programme: Health
Destination: Translating research for human health
Action type: Collaborative project
Countries involved: Italy,France,Germany,Italy,Spain,United Kingdom,Germany,Germany,Belgium,Germany,Australia,Malta,Germany,Germany,Netherlands
Call:  (FP7-HEALTH-2013-INNOVATION-1, 2013)
Start date: 2013-10-01
End date: 2018-09-30
Duration (months): 60.0
Total project cost (EUR): 16461000.77
EU funding (EUR): 11995646.0
Participants: 28
Project status: CLOSED

DESIRE will focus on epileptogenic developmental disorders EDD, i.e. early onset epilepsies whose origin is closely related to developmental brain processes. A major cause of EDD are malformations of cortical development (MCD), either macroscopic or subtle. EDD are often manifested as epileptic encephalopathies (EE), i.e. conditions in which epileptic activity itself may contribute to severe cognitive and behavioral impairments. EDD are the most frequent drug-resistant pediatric epilepsies carrying a lifelong perspective of disability and reduced quality of life. Although EDD collectively represent a major medical and socio-economic burden, their molecular diagnosis, pathogenic mechanisms (PM) and rationale treatment are poorly understood. Specific objectives of DESIRE are to advance the state of the art with respect to: (1) the genetic and epigenetic causes and PM of EDD, particularly epileptogenic MCD, to elucidate molecular networks and disrupted protein complexes and search for common bases for these apparently heterogeneous disorders. (2) the diagnostic tools (biomarkers) and protocols through the study of a unique and well-characterized cohort of children to provide standardized diagnosis for patient stratification and research across Europe. (3) treatment of EDD using randomized, multidisciplinary clinical protocols and testing preclinical strategies in experimental models to also address novel preventative strategies. The workplan spans from clinical observation, to whole exome studies, cellular and animal models and basic research, identification of biomarkers and improvement of diagnostic methods, and back to the clinical trials and assessment of innovative, targeted treatment strategies. The consortium partners have an outstanding track record in genetics, basic neurophysiology, neuropathology and clinical research. Specialized expertise will be made available by the SMEs involved to develop novel diagnostic tools for tailored treatment approaches.

Keywords: brain development,malformations of cortical development,focal cortical dysplasia,genetic epilepsies,epileptic encephalopathy,drug-resistant pediatric epilepsies,ketogenic diet,cognitive impairm
Mapping Chronic Non-Communicable Diseases Research Activities and their Impact (MAPPING_NCD)

Framework: FP7 — Cooperation
Programme: Health
Destination: Other Actions across the Health Theme
Action type: Coordination and support actions
Countries involved: United Kingdom,Germany,Spain,France,Italy,Estonia
Call:  (FP7-HEALTH-2013-INNOVATION-1, 2013)
Start date: 2014-01-01
End date: 2015-12-31
Duration (months): 24.0
Total project cost (EUR): 2238887.44
EU funding (EUR): 1997210.0
Participants: 7
Project status: CLOSED

MAPPING_NCD moves beyond the state of the art in the research area via three distinct means: by providing accurate mapping of research funding activities at Member State (MS) and European Union (EU) level; by providing bibliometric mapping and analysis of the volume of research outputs in the EU and MSs relevant to chronic non-communicable diseases (NCDs), and, by using input from both the above to provide an analysis of potential overlaps, synergies, gaps, opportunities and overall impact of NCD research funding to help identify a research agenda for the future. As a package, MAPPING_NCD comprises qualitative surveys of the five broad disease areas (diabetes and its complications; cardiovascular disease; cancer; mental health illnesses; and chronic respiratory diseases) and bibliometric analysis. It identifies current EU-funded, as well as national, regional and charitable research programs and initiatives in the field of NCDs, describing funding sources and overall investments and output. Using publications of research findings as a proxy indicator for research impact, it produces a high-resolution bibliometric analysis of the impact of NCD research by geographical distribution and characteristics, including: classification of NCD, individual disease and approaches to tackling the disease. Thus, MAPPING_NCD contributes to the capacity of the EU to develop evidence-based policies towards coordinated approaches to NCD research and initiatives. It also contributes to a cooperative approach to NCD research by providing the EU with crucial information about whether research funding is appropriately spent, by ensuring that future research activities are more efficient, and potentially, by freeing currently under-utilized resources to fund additional activities on under-researched areas both at MS and EU level.

Keywords: chronic non-communicable diseases european union research impact mapping policy
Natural sensory feedback for phantom limb pain modulation and therapy (EPIONE)

Framework: FP7 — Cooperation
Programme: Health
Destination: Translating research for human health
Action type: Collaborative project
Countries involved: Denmark,Italy,Switzerland,Germany,France,Sweden,United States,Spain,France
Call:  (FP7-HEALTH-2013-INNOVATION-1, 2013)
Start date: 2013-09-01
End date: 2017-08-31
Duration (months): 48.0
Total project cost (EUR): 8022135.14
EU funding (EUR): 5982840.0
Participants: 13
Project status: CLOSED

Amputation of a limb may result from trauma or surgical intervention. The amputation traumatically alters the body image, but often leaves sensations that refer to the missing body part. In 50-80% amputees, neuropathic pain develops, also called phantom limb pain (PLP). Both peripheral and central nervous system factors have been implicated as determinants of PLP. Also, PLP may be triggered by physical (changes in the weather) and psychological factors (emotional stress). Recent evidence suggests that PLP may be intricately related to neuroplastic changes in the cortex, and that these changes may modulated by providing sensory input to the stump or amputation zone. However, the understanding of why PLP occurs is still poor, the basic research results have not been tested on a large scale in the clinic, and there are no fully effective, long-term treatments readily available on the market. We aim to challenge the status-quo of PLP therapy by offering technological solutions that will invasively or non-invasively induce natural, meaningful sensations to the amputee to restore the neuroplastic changes in the cortex and thereby control and alleviate PLP. We will assess the effect of cortical neuroplastic, psychological and cognitive components of pain and integrate the knowledge into clinical guidelines. The proposed work directly targets the HEALTH.2013.2.2.1-5 topic. The consortium will build solutions based on existing technologies emerging from previous EU funded research which are presently only available in experimental settings. We believe that implementation of proposed work will be the cornerstone needed to exploit, validate and translate the basic research results into clinical applications and provide long-term, patient-specific solutions to a large group of patients suffering from PLP. The work will assist to improve the quality of life for amputees suffering from phantom limb pain and is of high socio-economic relevance to the EU.

Keywords: phantom limb pain,neuropathic pain,non-invasive sensory feedback,direct peripheral nerve feedback,psychological and cognitive components of pain
Bringing a modular technology for fresh water sea-transportation to full scale (XXL-REFRESH)

Framework: FP7 — Capacities
Programme: Research for the benefit of SMEs
Destination: Demonstration Activity
Action type: Collaborative project
Countries involved: Italy,Czechia,Italy,Spain,Spain,Spain,Türkiye
Call:  (FP7-SME-2013, 2013)
Start date: 2013-09-01
End date: 2015-12-31
Duration (months): 28.0
Total project cost (EUR): 1763944.7
EU funding (EUR): 989000.0
Participants: 7
Project status: CLOSED

XXL-REFRESH is built upon the results obtained by the REFRESH project (GA 262494), in which the project team demonstrated the feasibility of transportation of large quantities of fresh water by the sea using modular flexible barges. The key innovation introduced by REFRESH is the use of open modular textile containers connected by extra-strong watertight zips and the use of an online monitoring system for the control of the container deformations during service using wireless communication system. REFRESH culminated at the beginning of November 2012 with the successful transportation trial of 200 cubic metres freshwater payload with a 16 nautical miles sea voyage in the gulf of Souda, Crete. The next steps required to bring the innovation into the market comprise the manufacturing of a full-scale waterbag with a payload of 2.000 cubic metres and the conduction of demonstration voyages at different locations within Europe and outside. Technical activities covered by XXL-REFRESH include the design optimisation of the full-scale waterbag, implementing what learned during the trials in Crete, and the scaling up of the manufacturing processes for the manufacturing of one full-scale waterbag. Demonstration trials are included in the programme at two different locations in the Mediterranean Sea and outside, since the need for cost efficient and reliable technologies for fresh water transportation is global. Dissemination and exploitation activities are also included. The consortium includes five partners from the former REFRESH project complemented by two new partners in charge of confectioning the full-scale waterbag and performing the water transport service.

Keywords: water transportation technical textiles system modularity
Artistic robotic surface processing for stone (AROSU)

Framework: FP7 — Capacities
Programme: Research for the benefit of SMEs
Destination: Research for SMEs
Action type: Research for the benefit of specific groups
Countries involved: Germany,Italy,Germany,Germany,Austria,United Kingdom,Türkiye,Austria
Call:  (FP7-SME-2013, 2013)
Start date: 2013-12-01
End date: 2015-11-30
Duration (months): 24.0
Total project cost (EUR): 1544520.0
EU funding (EUR): 1184150.0
Participants: 8
Project status: CLOSED

Natural stone industry has a crucial importance at European level, and the overall worldwide demand for natural stone products is experiencing a steady growth; however, in the last years globalization is transforming the competitive scenario at a fast pace, with high technology available to most of worldwide players, who are able to offer good alternatives at extremely affordable prices; quality alone is therefore not able to keep up with the price gap, and the result is that the traditional European sculpturing and artistic stone processing is becoming an endangered art. It’s mandatory that the processes of artistic stone processing urgently evolves technologically to remain competitive in the international market, maintaining the inimitable artistic touch, at the same time keeping up with the new industrial requirements in terms of productivity and lean manufacturing. The main goal of the AROSU project is to advance and facilitate traditional artisan and art-work with new technologies, helping the European stone industry to lower their production costs by automating various production steps through a new flexible production concept. AROSU will implement a novel production concept able to extend industrial robot usage as an active assistant during the complex and demanding artistic work of hard natural stone carving. This will be achieved through the implementation of a novel robot cell able to produce artistic looking surfaces by implementing the following core components. 1) new robot mounted pneumatic chisel tool; 2)automated path generation from geometry data provided by a design interface for architects and artists. With AROSU it will be possible to improve the competitiveness of the stone processing industry, by drastically increasing the production efficiency through a novel co-operative workspace, in which sculptors and the robotic work-cell can jointly work on the natural product, with a vast range of different products with different sizes.

Keywords: industrial automation,material processing,robots