Agency: Cordis | Branch: FP7 | Program: BSG-SME | Phase: SME-2012-1 | Award Amount: 1.72M | Year: 2012
Rheumatoid arthritis (RA) and sistemic lupus erythematosus (SLE) are two autoimmune diseases that respectively affect an estimated population of 1.537.000 and 1.272.000 of patients in Europe. Such diseases show a long prodrome during which there are no clinical symptoms. In some cases, therapeutic treatments have been developed to improve patients quality of life. Therefore, reliable diagnostic/prognostic tools are necessary not only for an early diagnosis and for monitoring disease activity, but also for setting up personalized therapeutic treatments. The clinical diagnosis of RA and SLE is assisted by the use of in vitro diagnostic tests aimed at the evaluation of the presence/level of few autoantibodies circulating in serum. Yet, this diagnostic approach is unsatisfactory because it can assist the diagnosis only after the first disease onset, it is not useful to evaluate the disease susceptibility for an early prevention, and it does not provide information to follow the disease progression for the set up of personalized therapeutic treatments. To solve these drawbacks, the GAPAID project is aimed at supplying the SME participants of the scientific and technological activities necessary to develop a novel diagnostic / prognostic platform for patients affected by RA and SLE. To this aim the scientific activities will be focused on the discovery of the diagnostic and prognostic value of the genetic and serological profiles associated to RA and SLE. The technological activities will contribute to develop multiplex arrays for the contemporary detection of more analytes and to set up a software for the RA and SLE diagnosis / prognosis by matching the clinical, genetic, and serological data. The exploitation of the scientific and technological results will allow the SME participants to the GAPAID proposal to develop and to further commercialize both for RA and SLE an in vitro diagnostic product composed by a genetic array, a serological array, and a software.
Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2013.1.3-2 | Award Amount: 7.20M | Year: 2013
Europe is confronted by a demographic challenge as a decreasing work force has to support an increasing elderly population. The economic risk implied by this burden could be addressed by efforts to achieve an increase in Healthy Life Years. One key element would be to ensure unrestricted mobility for especially the elderly, allowing them to stay at work for longer. Irreversible joint deterioration often requires a joint replacement. Implantation of artificial joints is one of the most successful orthopaedic interventions. However, an increasing number of patients receive revision surgery with these 10 % of these contract an infection and 50 % develop an adverse immune reaction (AIR) to conventional implant material. At the moment the reasons for the development of AIR are inadequately understood. Our proposal contains innovative solutions concerning this problem. A predictive approach using biomarkers will identify patients with risk to develop AIR. These patients will receive hypoallergenic endoprostheses, avoiding AIR to conventional material. Novel hypoallergenic material combinations will be developed in the frame of this consortium by material scientists and implant manufacturer. Via immunological, microbiological and biocompatibility testing the development and production process will be improved constantly. The matching of implant material with the allergenic background of patients will avoid complicated and cost-intensive reverse reactions and is a step towards personalised medicine. A further approach is to achieve a better understanding of mechanisms of AIR, and its faster and easier diagnosis using sensitive diagnostic biomarkers for an accurate differentiation from low-grade infection. Additionally, mathematical modelling of results from different methods will show us the gene regulatory network that leads to an amplification of the adverse immune response triggered by prosthetic implants and will develop predictive models of AIR process.
Agency: Cordis | Branch: FP7 | Program: MC-ITN | Phase: PEOPLE-2007-1-1-ITN | Award Amount: 2.36M | Year: 2008
Multiple sclerosis (MS) is a chronic inflammatory, disabling disease of the central nervous system. Recent studies suggest that over the last 50 years a disproportional increase in incidence of MS in women has taken place. The lifetime costs of MS exceed 1.5 million per case in the UK, and are likely to be similar in other European countries. There is no definitive cure for MS. Immunomodulatory therapies, such as interferon- (IFN-) and glatiramer acetate (GA), are only partially effective. Hence, there is a pressing need both for novel therapeutic targets and for approaches toward increasing the effectiveness of these existing treatments. The focus of the proposed United Europeans for the development of PHArmacogenomics in MS (UEPHA-MS) network will be to promote and improve training opportunities in the novel areas of pharmacogenomics, biomarker research and systems biology applied to MS. The main scientific goals of this network are both to improve our knowledge of the mechanisms determining response outcome of existing immunomodulatory therapies and to identify novel therapeutic opportunities. UEPHA-MS is composed of ten internationally recognised research teams from 6 countries with an assortment of expertise in complementary disciplines. UEPHA-MS partners are among Europes most pro-active groups in pioneering the novel, supra-disciplinary area of integrated genomics / bioinformatics / systems biology research. The UEPHA-MS network will provide a coherent and internationally competitive platform for training of young scientists based on a series of state-of-the-art lab-based and network-wide activities. UEPHA-MS will boost employment perspectives of young researchers in Europes knowledge-based economy by shaping a new generation of scientists with greatly enhanced multidisciplinary aptitudes. This network will be crucial in priming young scientists for Europes collective effort toward improved provision of health care based on personalized medicine.
Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2012.2.1.2-1 | Award Amount: 3.64M | Year: 2013
Vaccine development is an empirical process (trial and error) and involves a long, expensive clinical development pipeline to license an efficacious vaccine candidate. Better tools for vaccine evaluation are needed to adapt to a rising number of candidate vaccines entering clinical trials for many diseases. Surrogate biomarkers of immunity offer the possibility of expediting the clinical development by eliminating non-viable candidates earlier in the pipeline, shortening vaccine trial timeframes by giving a proxy measurement for efficacy and by guiding future vaccine design. In the case of malaria and other complex diseases, a surrogate biomarker of immunity has been difficult to achieve with classical immunological assays. We propose using a systems biology analytical approach in two efficacious malaria vaccination models to identify combinatorial biomarkers of protection. First, newly generated cellular transcriptome profiles and previously generated immunological read-outs common to both trials will be integrated into a database for this analysis. An already developed artificial intelligence-based analytical tool that generates biological network maps, transforms experimental data to the map and discriminates transcriptional gene signatures to physiological states (protection or susceptibility) will be applied in both vaccination models. The aim is to determine malaria signatures of protection that will then be refined and validated in an experimentally induced immunity non-human primate model. The optimized model will be further validated on additional samples from the two protective human trials. The identified biomarkers of protection will be used to produce a customised Immunome Chip, which together with traditional immunological read-outs will be used to evaluate vaccine efficacy, shortening times and costs of clinical trials. This strategy may also prove useful for other diseases and support the systems medicine approach.
Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2012.1.2-1 | Award Amount: 6.35M | Year: 2012
Multiple Sclerosis (MS) is a devastating disease of the central nervous system affecting 2.5 million worldwide. MS is a field of constant therapeutic innovation, a fact which brings hope to young adults since MS is one of the most frequent causes of severe handicap. A major unmet need is to rationalize treatment decisions. To date, there is no way of predicting which patients will best respond to one of the 15 drugs expected on the market by 2014 and which patients are at risk of severe adverse effects. Recent technical advances (the omics revolution) have brought the dream of personalized medicine (PM) closer to reality. Therefore the main objective of this project is to design a composite test (using genome based biomarkers associated with clinical and radiological information) in order to predict which patients are associated with the best benefit to risk ratio in MS treatment, using Natalizumab (NTZ) as the paradigm. For this purpose, we have already built up a unique cohort of 1500 Europeans MS patients with. We will address 5 secondary objectives: #1 determine a qualitative definition of response to NTZ with clinical and radiological parameters; #2 determine a quantitative biological response test based on an in vitro assay; #3 determine DNA-based biomarkers associated with NTZ response; #4 determine genetic susceptibility to progressive multifocal encephalopathy and NTZ-related severe adverse events; and #5 determine RNA-based biomarkers associated with NTZ response. When this work is completed, we will use the data generated to build our composite test with a multivariate approach. We postulate that our predictive test for choosing the best patients to treat with NTZ will be a paradigm for all MS treatment and, beyond MS, for biotherapies in general. This project should have a positive impact on patients quality of life and on the MS market, and will involve a network of 5 teams (4 academic and 1 SME) that will work in perfect synergy.