Opendata, web and dolomites

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 €

0

EC-Contrib. €

0

Partnership

0

Views

0

 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.

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

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.

For instance: the website url (it has not provided by EU-opendata yet), the logo, a more detailed description of the project (in plain text as a rtf file or a word file), some pictures (as picture files, not embedded into any word file), twitter account, linkedin page, etc.

Send me an  email (fabio@fabiodisconzi.com) and I put them in your project's page as son as possible.

Thanks. And then put a link of this page into your project's website.

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

More projects from the same programme (H2020-EU.3.1.3.)

RESHAPE (2019)

Reshaping undesired Inflammation in challenged Tissue Homeostasis by Next-Generation regulatory T cell (Treg) Approaches – from Advanced Technology Developments to First-in-Human Trials

Read More  

GACD (2019)

Global Alliance for Chronic Diseases Secretariat

Read More  

LEGACy (2019)

CeLac and European consortium for a personalized medicine approach to Gastric Cancer

Read More