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TreatER SIGNED

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

Total Cost €

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EC-Contrib. €

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Partnership

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 TreatER project word cloud

Explore the words cloud of the TreatER project. It provides you a very rough idea of what is the project "TreatER" about.

conducting    neurological    countries    administered    toxicology    manufacturing    advancing    er    innovation    of    primates    pd    neurosurgical    indications    validated    protein    treatment    cdnf    sweden    placebo    imaging    disease    supporting    data    interdisciplinary    human    compounds    drug    safety    either    excellent    ema    neurosurgery    conventional    acute    parkinson    mhra    tested    innovative    diseases    clinically    proof    modification    intracerebrally    accurately    stress    needing    randomized    dds    therapy    profile    expertise    neurosurgically    first    extensive    infusions    finland    pet    itf    efficacy    patented    biological    utilized    technologies    goals    chronic    trial    implanted    medical    accordance    patients    advice    assessing    uk    clinical    gmp    builds    preclinical    validation    intracerebral    submitted    scientific    unmet    neurotrophic    previously    device    alone    treater    independent    regulatory   

Project "TreatER" data sheet

The following table provides information about the project.

Coordinator
HELSINGIN YLIOPISTO 

Organization address
address: YLIOPISTONKATU 3
city: HELSINGIN YLIOPISTO
postcode: 14
website: www.helsinki.fi

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country Finland [FI]
 Project website https://treater.eu/
 Total cost 8˙705˙549 €
 EC max contribution 5˙971˙173 € (69%)
 Programme 1. H2020-EU.3.1.3. (Treating and managing disease)
 Code Call H2020-SC1-2016-RTD
 Funding Scheme RIA
 Starting year 2017
 Duration (year-month-day) from 2017-01-01   to  2020-12-31

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    HELSINGIN YLIOPISTO FI (HELSINGIN YLIOPISTO) coordinator 597˙000.00
2    REGION STOCKHOLM SE (STOCKHOLM) participant 963˙125.00
3    HERANTIS PHARMA OYJ FI (ESPOO) participant 900˙000.00
4    HELSINGIN JA UUDENMAAN SAIRAANHOITOPIIRIN KUNTAYHTYMÄ FI (HELSINKI) participant 738˙125.00
5    SKANE LANS LANDSTING SE (KRISTIANSTAD) participant 716˙395.00
6    RENISHAW PLC UK (WOTTON UNDER EDGE) participant 700˙000.00
7    THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD UK (OXFORD) participant 589˙028.00
8    KAROLINSKA INSTITUTET SE (STOCKHOLM) participant 525˙625.00
9    ASSOCIATION EUROPEENNE POUR LA MALADIE DE PARKINSON BE (BRUXELLES) participant 144˙375.00
10    H. LUNDBECK AS DK (VALBY) participant 48˙750.00
11    ORION OYJ FI (ESPOO) participant 48˙750.00

Map

 Project 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.

 Deliverables

List of deliverables.
Midterm recruitment report, extension study Documents, reports 2020-03-25 16:14:59
Midterm progress report WP4 Documents, reports 2020-03-25 16:14:59
Midterm recruitment report Documents, reports 2020-03-25 16:14:59
Patient information website Websites, patent fillings, videos etc. 2020-03-25 16:14:59

Take a look to the deliverables list in detail:  detailed list of TreatER deliverables.

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The information about "TREATER" are provided by the European Opendata Portal: CORDIS opendata.

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