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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.

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

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.

Are you the coordinator (or a participant) of this project? Plaese send me more information about the "TREATER" project.

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

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