Objective The main focus of TreatER is conducting a randomized, placebo-controlled, first-in-human, proof-of-concept, safety and efficacy study of intracerebrally administered CDNF protein therapy in patients with Parkinson’s disease (PD), using a neurosurgically implanted Drug Delivery System (DDS), which will also be clinically validated in the study. Thus the TreatER project has two independent goals, either of which alone can have significant impact addressing unmet clinical needs in chronic diseases, and advancing innovative European technologies:1) Proof-of-concept of CDNF protein therapy for disease modification in PD. The patented European innovation CDNF has further potential in other ER stress related indications.2) Clinical validation of DDS, an already clinically tested approach for accurately targeted intracerebral infusions in PD. The patented European innovation DDS has also significant potential in other indications needing intracerebral infusions.The clinical study builds on extensive preclinical research and related data on CDNF, including completed acute and chronic toxicology studies in non-human primates supporting an excellent safety profile. Further, the clinical study builds on existing clinical experience on DDS and related neurosurgery.Both conventional and novel means for assessing the efficacy of the treatment will be utilized. This requires strong interdisciplinary expertise and knowledge available in the consortium, including: Regulatory expertise in drug and medical device development; neurological and neurosurgical expertise in PD; PET imaging expertise specific to PD; Scientific expertise in novel neurotrophic factors, in specific CDNF; and GMP manufacturing expertise of novel biological drug compounds.Clinical trial applications are currently being submitted in Finland and Sweden, in accordance with previously obtained scientific advice from regulatory authorities in those countries as well as from MHRA (UK) and EMA's ITF. Keywords Parkinson's disease ER stress endoplasmic reticulum stress CDNF intracerebral administration Programme(s) H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being Main Programme H2020-EU.3.1.3. - Treating and managing disease Topic(s) SC1-PM-09-2016 - New therapies for chronic diseases Call for proposal H2020-SC1-2016-2017 See other projects for this call Sub call H2020-SC1-2016-RTD Funding Scheme RIA - Coordinator HELSINGIN YLIOPISTO Net EU contribution € 597 000,00 Address Yliopistonkatu 3 00014 Helsingin yliopisto Finland See on map Region Manner-Suomi Helsinki-Uusimaa Helsinki-Uusimaa Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 Participants (13) Sort alphabetically Sort by Net EU contribution Expand all Collapse all RENISHAW PLC Participation ended United Kingdom Net EU contribution € 0,00 Address New mills GL12 8JR Wotton under edge See on map Region South West (England) Gloucestershire, Wiltshire and Bristol/Bath area Gloucestershire Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 Third-party Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure. Renishaw (Ireland) Ltd Participation ended Ireland Net EU contribution € 0,00 Address Swords business park GL128JR Dublin See on map Region Ireland Eastern and Midland Dublin Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 REGION SKANE Sweden Net EU contribution € 716 395,00 Address Region skane 291 89 Kristianstad See on map Region Södra Sverige Sydsverige Skåne län Activity type Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 HUS-YHTYMA Finland Net EU contribution € 738 125,00 Address Stenbackinkatu 9 00029 Helsinki See on map Region Manner-Suomi Helsinki-Uusimaa Helsinki-Uusimaa Activity type Research Organisations Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 REGION STOCKHOLM Sweden Net EU contribution € 963 125,00 Address Hantverkargatan 45 104 22 Stockholm See on map Region Östra Sverige Stockholm Stockholms län Activity type Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 KAROLINSKA INSTITUTET Sweden Net EU contribution € 525 625,00 Address Nobels vag 5 17177 Stockholm See on map Region Östra Sverige Stockholm Stockholms län Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 HERANTIS PHARMA OYJ Finland Net EU contribution € 900 000,00 Address Bertel jungin aukio 1 02600 Espoo See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Manner-Suomi Helsinki-Uusimaa Helsinki-Uusimaa Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 1 743 026,00 ASSOCIATION EUROPEENNE POUR LA MALADIE DE PARKINSON Belgium Net EU contribution € 144 375,00 Address Avenue besme 93 1190 Bruxelles / brussel See on map Region Région de Bruxelles-Capitale/Brussels Hoofdstedelijk Gewest Région de Bruxelles-Capitale/ Brussels Hoofdstedelijk Gewest Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad Activity type Other Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 ORION OYJ Finland Net EU contribution € 48 750,00 Address Orionintie 1 02200 Espoo See on map Region Manner-Suomi Helsinki-Uusimaa Helsinki-Uusimaa Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD United Kingdom Net EU contribution € 589 028,75 Address Wellington square university offices OX1 2JD Oxford See on map Region South East (England) Berkshire, Buckinghamshire and Oxfordshire Oxfordshire Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 H. LUNDBECK AS Denmark Net EU contribution € 48 750,00 Address Ottiliavej 7-9 2500 Valby See on map Region Danmark Hovedstaden Byen København Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 RENISHAW NEURO SOLUTIONS LTD United Kingdom Net EU contribution € 256 840,00 Address Wotton road GL12 8SP Charfield See on map Region South West (England) Gloucestershire, Wiltshire and Bristol/Bath area Gloucestershire Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 363 740,00 Third-party Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure. Renishaw (Ireland) Ltd Ireland Net EU contribution € 443 160,00 Address Swords business park GL128JR Dublin See on map Region Ireland Eastern and Midland Dublin Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 627 610,00
