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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.

Field of science

  • /social sciences/sociology/anthropology/physical anthropology
  • /medical and health sciences/basic medicine/neurology/parkinson
  • /medical and health sciences/basic medicine/toxicology
  • /natural sciences/biological sciences/zoology/mammalogy/primatology

Call for proposal

H2020-SC1-2016-RTD
See other projects for this call

Funding Scheme

RIA - Research and Innovation action

Coordinator

HELSINGIN YLIOPISTO
Address
Yliopistonkatu 3
00014 Helsingin Yliopisto
Finland
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 597 000

Participants (10)

RENISHAW PLC
United Kingdom
EU contribution
€ 700 000
Address
New Mills
GL12 8JR Wotton Under Edge
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
SKANE LANS LANDSTING
Sweden
EU contribution
€ 716 395
Address
.
291 89 Kristianstad
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
HELSINGIN JA UUDENMAAN SAIRAANHOITOPIIRIN KUNTAYHTYMÄ
Finland
EU contribution
€ 738 125
Address
Stenbackinkatu 9
00029 Helsinki
Activity type
Research Organisations
REGION STOCKHOLM
Sweden
EU contribution
€ 963 125
Address
Hantverkargatan 45
104 22 Stockholm
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
KAROLINSKA INSTITUTET
Sweden
EU contribution
€ 525 625
Address
Nobels Vag 5
17177 Stockholm
Activity type
Higher or Secondary Education Establishments
HERANTIS PHARMA OYJ
Finland
EU contribution
€ 900 000
Address
Bertel Jungin Aukio 1
02600 Espoo
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
ASSOCIATION EUROPEENNE POUR LA MALADIE DE PARKINSON
Belgium
EU contribution
€ 144 375
Address
Avenue Besme 93
1190 Bruxelles
Activity type
Other
ORION OYJ
Finland
EU contribution
€ 48 750
Address
Orionintie 1
02200 Espoo
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD
United Kingdom
EU contribution
€ 589 028,75
Address
Wellington Square University Offices
OX1 2JD Oxford
Activity type
Higher or Secondary Education Establishments
H. LUNDBECK AS
Denmark
EU contribution
€ 48 750
Address
Ottiliavej 7-9
2500 Valby
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)