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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.
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Coordinator

HELSINGIN YLIOPISTO

Address

Yliopistonkatu 3
00014 Helsingin Yliopisto

Finland

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 597 000

Participants (10)

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RENISHAW PLC

United Kingdom

EU Contribution

€ 700 000

SKANE LANS LANDSTING

Sweden

EU Contribution

€ 716 395

HELSINGIN JA UUDENMAAN SAIRAANHOITOPIIRIN KUNTAYHTYMÄ

Finland

EU Contribution

€ 738 125

STOCKHOLMS LANS LANDSTING

Sweden

EU Contribution

€ 963 125

KAROLINSKA INSTITUTET

Sweden

EU Contribution

€ 525 625

HERANTIS PHARMA OYJ

Finland

EU Contribution

€ 900 000

ASSOCIATION EUROPEENNE POUR LA MALADIE DE PARKINSON

Belgium

EU Contribution

€ 144 375

ORION OYJ

Finland

EU Contribution

€ 48 750

THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD

United Kingdom

EU Contribution

€ 589 028,75

H. LUNDBECK AS

Denmark

EU Contribution

€ 48 750

Project information

Grant agreement ID: 732386

Status

Ongoing project

  • Start date

    1 January 2017

  • End date

    31 December 2019

Funded under:

H2020-EU.3.1.3.

  • Overall budget:

    € 8 705 549,75

  • EU contribution

    € 5 971 173,75

Coordinated by:

HELSINGIN YLIOPISTO

Finland