Institute Curie, French National Center for Scientific Research, French Institute of Health, Medical Research, Assistance Publique Hopitaux De Paris and University of Paris Descartes | Date: 2016-07-29
A composition that can be used as a vaccine containing means for targeting at least one antigen to dendritic cells and as adjuvants a granulocyte macrophage colony stimulating factor and a CpG oligodeoxynucleotide and/or a CpG-like oligodeoxynucleotide. This composition can used to treat cancers, infectious diseases caused by bacterial, viral, fungal, parasitic or protozoan infections, allergies and/or autoimmune diseases.
French Institute of Health, Medical Research, Assistance Publique Hopitaux De Paris and Indiana University | Date: 2016-11-17
French Institute of Health, Medical Research, Montpellier University, Assistance Publique Hopitaux De Paris, University Paris Est Creteil and University of Angers | Date: 2016-10-17
The present invention relates to methods and pharmaceutical compositions for cardioprotection of subjects who experienced a myocardial infarction. In particular, the present invention relates to a ligand of the sonic hedgehog signaling pathway for use in the cardioprotection of a subject who experienced a myocardial infarction.
Agency: Cordis | Branch: H2020 | Program: RIA | Phase: PHC-11-2015 | Award Amount: 7.42M | Year: 2016
Cancer is the second leading cause of mortality in EU member states with ~90% of all cancer deaths caused by metastatic spread. Despite its significance, measuring metastatic potential as well as potential indicators of therapy efficacy remain unmet clinical challenges. Recently, it has been demonstrated in vitro, that aggressive metastatic cells pull on their surroundings suggesting that metastatic potential could be gauged by measuring the forces exert by tumours. Furthermore, many solid tumours show a significantly increased interstitial fluid pressure (IFP) which prevents the efficient uptake of therapeutic agents. As a result, a reduction in IFP is recognized as a hallmark of therapeutic efficacy. Currently, there is no non-invasive modality that can directly image these forces in vivo. Our objective is the non-invasive measurement of both IFP within tumours as well as the forces they exert on their surrounding environment. This will be used to predict a tumours metastatic potential and importantly, changes in these forces will be used to predict the therapeutic efficacy of drug therapy. To attain this goal, the biomechanical properties of the tumour and its neighbouring tissue will be measured via MR-elastography at various measured deformation states. Resultant images will be used to reconstruct images of the internal and external forces acting on the tumour. We call this novel imaging modality Magnetic Resonance Force (MRF) imaging. We will calibrate MRF via cell cultures and pre-clinical models, and then test the method in breast, liver, and brain cancer patients. Thereby, we will investigate whether MRF data can predict metastatic spread and measure IFP in patients. We will also investigate the potential to non-invasively modulate the force environment of cancer cells via externally applied shear forces with the aim of impacting cell motility and proliferation. This can provide novel mechanism for anticancer therapeutic agents via mechanotransduction.
Agency: Cordis | Branch: H2020 | Program: RIA | Phase: PHC-30-2015 | Award Amount: 3.34M | Year: 2016
Breast cancer is the most common type of cancer affecting woman in the EU. Multidisciplinary Breast Units (BUs) were introduced in order to deal efficiently with breast cancer cases, setting guideline-based quality procedures and a high standard of care. However, daily practice in the BUs is hampered by the complexity of the disease, the vast amount of patient and disease data available in the digital era, the difficulty in coordination, the pressure exerted by the system and the difficulty in deciding on cases that guidelines do not reflect. DESIREE aims to alleviate this situation by providing a web-based software ecosystem for the personalized, collaborative and multidisciplinary management of primary breast cancer (PBC) by specialized BUs. Decision support will be provided on the available therapy options by incorporating experience from previous cases and outcomes into an evolving knowledge model, going beyond the limitations of the few existing guideline-based decision support systems (DSS). Patient cases will be represented by a novel digital breast cancer patient (DBCP) data model, incorporating variables relevant for decision and novel sources of information and biomarkers of diagnostic and prognostic value, providing a holistic view of the patient presented to the BU through specialized visual exploratory interfaces. The influence of new variables and biomarkers in current and previous cases will be explored by a set of data mining and visual analytics tools, leveraging large amounts of retrospective data. Iintuitive web-based tools for multi-modality image analysis and fusion will be developed, providing advanced imaging biomarkers for breast and tumor characterization. Finally, a predictive tool for breast conservative therapy will be incorporated, based on a multi-scale physiological model, allowing to predict the aesthetic outcome of the intervention and the healing process, with important clinical and psychological implications for the patients.
Agency: Cordis | Branch: H2020 | Program: RIA | Phase: FETOPEN-01-2016-2017 | Award Amount: 3.99M | Year: 2017
ArrestAD proposes a novel and visionary thinking resulting from the demonstration of the central role of a particular heparan sulfate species at the intracellular level in neurons and in circulating cells in the molecular pathology of Alzheimers disease (AD). AD is a societal challenge for which there is neither prevention nor possible cure. Research in the field has long been refining classic concepts based on the aggregation of A and tau through initial seeding and then spreading. Our vision is different and based on the demonstration that tau abnormal phosphorylation and aggregation is triggered by the interaction of tau with heparan sulfates internalized in neurons and circulating cells only in AD [UPEC R.1; P.1,2]. Based in this new concept, ArrestAD will establish links between AD genetics, disease hallmarks, and altered traffic and intracellular accumulation of heparan sulfates to generate new knowledge underpinning the development of new strategies for detection and treatment of AD. This will open to radically new technologies addressing two major objectives: 1) proving that specific and early diagnosis of AD is possible in circulating cells, and 2) demonstrating that a new class of drug candidates are able to preventing and/or arresting AD-neurodegeneration. To reach these objectives, ArrestAD brings together internationally recognized experts in AD clinics and diagnosis, in heparan sulfate biology, transcriptomics, interactomics, carbohydrate chemistry, enzymology, cell biology, animal experimentation with AD models, and a SME specialized in the development of diagnosis kits using circulating cells. The high-risk character of this joint science and technology research is offset by the multidisciplinary nature of the Consortium and the high socio-economic gain resulting from success. Based in this technology, we will build a diverse portfolio of future projects that will result in a long-term benefit for citizens, economy and society.
Agency: Cordis | Branch: H2020 | Program: RIA | Phase: SC1-PM-09-2016 | Award Amount: 6.00M | Year: 2017
Liver cirrhosis is a very common chronic disease and one of the leading causes of death in European. Moreover, cirrhosis has a marked impact in patients quality of life and represents a major burden for health systems. Treatment of cirrhosis is currently based on symptomatic management of complications and has not changed substantially in the last 20 years. There is an unmet need for therapies that target the pathobiology of cirrhosis. The objective of LIVERHOPE project is to evaluate a novel therapeutic strategy for patients with cirrhosis based on a combination of rifaximin and simvastatin, targeting the main pathophysiological mechanisms of disease progression , namely the impairment in the gut-liver axis and the persistent hepatic and systemic inflammatory response. This dual therapeutic approach is supported by preclinical data showing excellent and very promising results. We will perform two randomized double-blind trials to investigate safety, tolerability and efficacy of combination of simvastatin plus rifaximin in patients with decompensated cirrhosis in 5 EU countries (285 patients will be enrolled in two trials in DE, ES, FR, IT, UK). The expected impact is to halt progression to acute-on-chronic liver failure, the main cause of death, to decrease complications of the disease, to reduce hospital readmissions, to improve cost-effectiveness of therapy. Our final aim is to improve patients quality-of-life and increase survival as patients care is the core of LIVERHOPE. Within the project we will also investigate biomarkers of response to treatment and disease progression that can be useful in clinical practice for improving the treatment of patients. We will invest our effort also in communication and dissemination activities for increasing awareness about chronic liver diseases in European countries so that preventive measures can be established to decrease the burden of cirrhosis and reduce social stigmatization of patients with chronic liver diseases.
Agency: Cordis | Branch: H2020 | Program: RIA | Phase: SC1-PM-09-2016 | Award Amount: 6.75M | Year: 2017
The main goal of HIVACAR proposal is to change the current paradigm of HIV treatment by obtaining a functional cure for HIV (i.e., control of viral load to levels below the threshold of 50 copies/ml and maintenance of high CD4\ T-cell count after discontinuation of antiretroviral therapy) thanks to effectively targeting residual virus replication and viral reservoirs. In order to do so, the planned novel strategy is to successfully combine immune-based therapies, including therapeutic vaccines and broadly neutralizing antibodies with latency reversing agents, in a proof-of-concept phase IIa clinical trial. HIVACAR project will lead to a reduction of the actual costs related to HIV treatment and management and of the social public health as well as an improvement in the patients quality of life. HIVACAR project has been conceived under the framework of responsible research and innovation, so patients and other stakeholders will have a key role from the inception of the project until obtaining the results. Patients will be perfectly aware of how this therapy has been conceived and the real impact and change in their actual quality of life, as well as how the clinical trial has been designed and the consequences of participating in it. In addition, patients (and the general population) will tailor the project and its results dissemination and communication. This patient engagement will not be limited to the clinical trial but also to the rest of the activities of the project, so patients and the general society will be aware of how the research is developed and can include the patients point of view in the research activities. In addition, the socio-economic and psycho-social impact of the new treatment will be also analysed so overwhelming data on the benefits and impact of the new treatment will be obtained and shown to all the stakeholders.
RESPINE - REgenerative therapy of intervertebral disc: a double blind phase 2b trial of intradiscal injection of mesenchymal stromal cells in degenerative disc disease of the lomber SPINE unresponsive to conventional therapy
Agency: Cordis | Branch: H2020 | Program: RIA | Phase: SC1-PM-11-2016-2017 | Award Amount: 5.56M | Year: 2017
The World Health Organisation (WHO) has included low back pain in its list of twelve priority diseases. Notably, Degenerative disc disease (DDD) presents a large, unmet medical need which results in a disabling loss of mechanical function. Today, no efficient therapy is available. Chronic cases often receive surgery, which may lead to biomechanical problems and accelerated degeneration of adjacent segments. Our consortium partners have developed and studied stem cell-based, regenerative therapies with encouraging results in phase 1 and 2a trials. Patients exhibited rapid and progressive improvement of functional and pain indexes by 50% within 6 months and by 65% to 78% after 1 year with no side effects. In addition, MRI T2 relaxation measurements demonstrated a significant improvement. To develop the worlds first rigorously proven, effective treatment of DDD, RESPINE aims to assess, via a multicentre, randomized, controlled, phase 2b clinical trial including 112 patients with DDD, the efficacy of an allogenic intervertebral mesenchymal stem cell (MSC)-based therapy. This innovative therapy aims to rapidly (within 3 months) and sustainably (at least 24 months) reduce pain and disability. In addition, the consortium aims to provide new knowledge on immune response & safety associated with allogeneic BM-MSC intradiscal injection. This simple procedure would be cost-effective, minimally invasive, and standardised. The transfer to the clinic will be prepared at a cost below 10k thanks to the strategy of production of allogenic cells, automation & EU standardisation. At the end of the RESPINE trial, we aim to propose a broadly available and clinically applicable treatment for DDD, marketed by European SMEs.
Agency: Cordis | Branch: H2020 | Program: RIA | Phase: SC1-PM-09-2016 | Award Amount: 7.85M | Year: 2017
Liver disease incidence is increasing and about 170K patients die from liver failure each year in Europe. In liver failure, the accumulation of protein bound toxins and increased susceptibility to infection cause multiorgan failure and death. Liver transplantation is the only treatment known to prolong the life but is limited by availability of organs. A clinically efficacious liver dialysis device is an unmet clinical need. The ALIVER Consortium has developed and optimised a novel liver dialysis device, DIALIVE. The DIALIVE device is protected by world-wide patents and is based upon our discovery that (i) albumin, a circulating protein involved in detoxification is reduced irreversibly in function and (ii) endotoxemia contributes to increased risk of infection in liver failure. DIALIVE incorporates albumin removal and replacement and, endotoxin removal and is a TRL5. In animal models of liver failure, DIALIVE was shown to be easy to use, safe, reduced endotoxemia and, improved albumin and immune function and, prolonged survival. The ALIVER Consortium, which is comprised of experts in liver failure, SMEs and charities proposes to perform clinical trials of DIALIVE in patients with acute on chronic liver failure (ACLF). During the grant period a CE-mark will be obtained and the device will progress to a TRL7/8. Consultation with Regulatory bodies confirms that if the trials are successful, a CE-mark is highly likely. Grifols, a large plasma proteins company is a potential licensee of the technology if the studies proposed by the ALIVER Consortium are positive. We plan to take the project through regulatory and ethics approval and perform two studies to define its safety and efficacy in ACLF patients in 18 European hospitals; define health economic benefits to the EU and define a reimbursement strategy. The results will be disseminated widely and results exploited to benefit patients, EU healthcare system, create new jobs and grow healthcare Industry in Europe.