Objective Allergy is the most prevalent chronic inflammatory disease, having great socio-economic impact. Chronic lifelong dependency on symptomatic drugs is an expensive reality for the vast majority of allergy sufferers. Allergen-specific immunotherapy is the only causal and effective treatment targeting the underlying immune mechanism in a more cost-effective way. Yet, long treatment duration and risk of anaphylactic side-effects have prevented this treatment from becoming the first choice. BM4SIT aims at providing an escape from its current niche position by making the treatment safer, more effective and patient friendlier, i.e. developing a therapywith negligible side-effects but improved efficacy, achieved by less injections. The concept of BM4SIT is based on two innovations: replacing current natural allergen extracts by mutated recombinant allergens having been designed to be hypo-allergenic but hyper-immunogenic, and adding an adjuvant to support rapid and effective induction of an anti-inflammatory immune response. The allergen derivative chosen to bring this concept from bench to bedside is BM41, a mutant of the culprit allergen of birch pollen allergy, Bet v 1. Pre-clinical data have demonstrated strongly reduced allergenicity, significantly increased immunogenicity and efficacy in a mouse model for birch pollen allergy. The selected adjuvant is vitamin D3, which has been shown to promote active suppression of inflammation, both in vitro and in a mouse model. The product-focused, IP-protected consortium of BM4SIT will test the immunological and clinical added value of vitamin D3in combination with a current product in a randomized DBPC trial. First-in-man safety of BM41 will be evaluated against placebo, using a current product as comparator. Preliminary efficacy data will be obtained using surrogate in vitro serological and cellular tests. Fields of science medical and health scienceshealth sciencesinflammatory diseasesmedical and health sciencesclinical medicineallergologymedical and health sciencesbasic medicineimmunologyimmunotherapy Programme(s) FP7-HEALTH - Specific Programme "Cooperation": Health Topic(s) HEALTH.2013.1.3-3 - Safety and efficacy of therapeutic vaccines Call for proposal FP7-HEALTH-2013-INNOVATION-1 See other projects for this call Funding Scheme CP-FP - Small or medium-scale focused research project Coordinator ACADEMISCH MEDISCH CENTRUM BIJ DE UNIVERSITEIT VAN AMSTERDAM EU contribution € 3 065 458,00 Address MEIBERGDREEF 15 1105AZ Amsterdam Netherlands See on map Region West-Nederland Noord-Holland Groot-Amsterdam Activity type Higher or Secondary Education Establishments Administrative Contact Frank Groen (Mr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data Participants (9) Sort alphabetically Sort by EU Contribution Expand all Collapse all PARIS-LODRON-UNIVERSITAT SALZBURG Austria EU contribution € 515 800,00 Address KAPITELGASSE 4-6 5020 Salzburg See on map Region Westösterreich Salzburg Salzburg und Umgebung Activity type Higher or Secondary Education Establishments Administrative Contact Doris Stampfer (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data HAL ALLERGY BV Participation ended Netherlands EU contribution € 46 500,00 Address J H OORTWEG 15 2333 CH LEIDEN See on map Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Coos Bos (Mr.) Links Contact the organisation Opens in new window Total cost No data BIOMAY AG Austria EU contribution € 1 302 750,00 Address LAZARETTGASSE 19 1090 WIEN See on map Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Karl Fister (Mr.) Links Contact the organisation Opens in new window Total cost No data ODENSE UNIVERSITETSHOSPITAL Denmark EU contribution € 452 400,00 Address Sdr. Boulevard 29 5000 ODENSE See on map Activity type Research Organisations Administrative Contact Weber Strate Lars (Mr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data RUPRECHT-KARLS-UNIVERSITAET HEIDELBERG Germany EU contribution € 118 500,00 Address SEMINARSTRASSE 2 69117 Heidelberg See on map Region Baden-Württemberg Karlsruhe Heidelberg, Stadtkreis Activity type Higher or Secondary Education Establishments Administrative Contact Dieter Manthey (Dr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data ALL-MED SPECJALISTYCZNA OPIEKA MEDYCZNA Poland EU contribution € 55 500,00 Address SEPIA 38 53 143 WROCLAW See on map Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Marek Jutel (Prof.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data TURUN YLIOPISTO Finland EU contribution € 287 700,00 Address YLIOPISTONMAKI 20014 Turku See on map Region Manner-Suomi Etelä-Suomi Varsinais-Suomi Activity type Higher or Secondary Education Establishments Administrative Contact Mari Riipinen (Dr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data CLINICAL TRIAL CENTER MAASTRICHT Participation ended Netherlands EU contribution € 30 600,00 Address OXFORDLAAN 70 6229 EV Maastricht See on map Region Zuid-Nederland Limburg (NL) Zuid-Limburg Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Carl De Bont (Mr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data EVIDENCE-BASED HEALTH CARE LTD United Kingdom EU contribution € 121 200,00 Address 113 THE MURRAYS EH17 8UD EDINBURGH See on map Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Sangeeta Dhami (Dr.) Links Contact the organisation Opens in new window Total cost No data
