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Clinical study in Parkinson's disease with two unique goals: 1) Proof-of-concept of CDNF protein for disease modification; 2) Validation of clinically tested device for intracerebral drug delivery

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.

Call for proposal

H2020-SC1-2016-2017

See other projects for this call

Sub call

H2020-SC1-2016-RTD

Coordinator

HELSINGIN YLIOPISTO
Net EU contribution
€ 597 000,00
Address
Yliopistonkatu 3
00014 Helsingin Yliopisto
Finland

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Region
Manner-Suomi Helsinki-Uusimaa Helsinki-Uusimaa
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00

Participants (13)

RENISHAW PLC

Participation ended

United Kingdom
Net EU contribution
€ 0,00
Address
New Mills
GL12 8JR Wotton Under Edge

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Region
South West (England) Gloucestershire, Wiltshire and Bristol/Bath area Gloucestershire
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 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

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Region
Ireland Eastern and Midland Dublin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
REGION SKANE
Sweden
Net EU contribution
€ 716 395,00
Address
Region Skane
291 89 Kristianstad

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Region
Södra Sverige Sydsverige Skåne län
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Non-EU contribution
€ 0,00
HELSINGIN JA UUDENMAAN SAIRAANHOITOPIIRIN KUNTAYHTYMÄ
Finland
Net EU contribution
€ 738 125,00
Address
Stenbackinkatu 9
00029 Helsinki

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Region
Manner-Suomi Helsinki-Uusimaa Helsinki-Uusimaa
Activity type
Research Organisations
Non-EU contribution
€ 0,00
REGION STOCKHOLM
Sweden
Net EU contribution
€ 963 125,00
Address
Hantverkargatan 45
104 22 Stockholm

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Region
Östra Sverige Stockholm Stockholms län
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Non-EU contribution
€ 0,00
KAROLINSKA INSTITUTET
Sweden
Net EU contribution
€ 525 625,00
Address
Nobels Vag 5
17177 Stockholm

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Region
Östra Sverige Stockholm Stockholms län
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
HERANTIS PHARMA OYJ
Finland
Net EU contribution
€ 900 000,00
Address
Bertel Jungin Aukio 1
02600 Espoo

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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)
Non-EU contribution
€ 1 743 026,00
ASSOCIATION EUROPEENNE POUR LA MALADIE DE PARKINSON
Belgium
Net EU contribution
€ 144 375,00
Address
Avenue Besme 93
1190 Bruxelles

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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
Non-EU contribution
€ 0,00
ORION OYJ
Finland
Net EU contribution
€ 48 750,00
Address
Orionintie 1
02200 Espoo

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Region
Manner-Suomi Helsinki-Uusimaa Helsinki-Uusimaa
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 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

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Region
South East (England) Berkshire, Buckinghamshire and Oxfordshire Oxfordshire
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
H. LUNDBECK AS
Denmark
Net EU contribution
€ 48 750,00
Address
Ottiliavej 7-9
2500 Valby

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Region
Danmark Hovedstaden Byen København
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
RENISHAW NEURO SOLUTIONS LTD
United Kingdom
Net EU contribution
€ 256 840,00
Address
Wotton Road
GL12 8SP Charfield

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Region
South West (England) Gloucestershire, Wiltshire and Bristol/Bath area Gloucestershire
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 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

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Region
Ireland Eastern and Midland Dublin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 627 610,00