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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 €

EC-Contrib. €

Partnership

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Outcomes and
results

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.

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

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 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.	FI (HELSINGIN YLIOPISTO)	coordinator	597˙000.00
2	REGION STOCKHOLM REGION STOCKHOLM Organization address address: HANTVERKARGATAN 45 city: STOCKHOLM postcode: 104 22 website: www.sll.se contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	SE (STOCKHOLM)	participant	963˙125.00
3	HERANTIS PHARMA OYJ HERANTIS PHARMA OYJ Organization address address: BERTEL JUNGIN AUKIO 1 city: ESPOO postcode: 2600 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FI (ESPOO)	participant	900˙000.00
4	HELSINGIN JA UUDENMAAN SAIRAANHOITOPIIRIN KUNTAYHTYMÄ HELSINGIN JA UUDENMAAN SAIRAANHOITOPIIRIN KUNTAYHTYMÄ Organization address address: STENBACKINKATU 9 city: HELSINKI postcode: 29 website: www.hus.fi contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FI (HELSINKI)	participant	738˙125.00
5	SKANE LANS LANDSTING SKANE LANS LANDSTING Organization address address: . city: KRISTIANSTAD postcode: 291 89 website: www.skane.se contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	SE (KRISTIANSTAD)	participant	716˙395.00
6	RENISHAW PLC RENISHAW PLC Organization address address: NEW MILLS city: WOTTON UNDER EDGE postcode: GL12 8JR website: www.renishaw.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (WOTTON UNDER EDGE)	participant	700˙000.00
7	THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD Organization address address: WELLINGTON SQUARE UNIVERSITY OFFICES city: OXFORD postcode: OX1 2JD website: www.ox.ac.uk contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (OXFORD)	participant	589˙028.00
8	KAROLINSKA INSTITUTET KAROLINSKA INSTITUTET Organization address address: Nobels Vag 5 city: STOCKHOLM postcode: 17177 website: www.ki.se contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	SE (STOCKHOLM)	participant	525˙625.00
9	ASSOCIATION EUROPEENNE POUR LA MALADIE DE PARKINSON ASSOCIATION EUROPEENNE POUR LA MALADIE DE PARKINSON Organization address address: AVENUE BESME 93 city: BRUXELLES postcode: 1190 website: www.epda.eu.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	BE (BRUXELLES)	participant	144˙375.00
10	H. LUNDBECK AS H. LUNDBECK AS Organization address address: OTTILIAVEJ 7-9 city: VALBY postcode: 2500 website: www.lundbeck.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DK (VALBY)	participant	48˙750.00
11	ORION OYJ ORION OYJ Organization address address: ORIONINTIE 1 city: ESPOO postcode: 2200 website: http://www.orion.fi/en/ contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	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.