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OligoGpivotalCF SIGNED

A pivotal phase IIb clinical trial of inhaled alginate oligosaccharide (OligoG) for cystic fibrosis

Total Cost €

EC-Contrib. €

Partnership

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Outcomes and
results

OligoGpivotalCF project word cloud

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

vitro patient questionnaires drug designation cmaa biofilm sought cf marketing outcomes criteria fda stagnant susceptibility network successful seaweed 2007 assistance index pulmonary follow scientific authorisation advice mucus conditional final fibrosis bacterial received vivo medicines trial ex lci exploratory protocol 2016 cfq culture oligog cystic disease function endpoints sites oligosaccharide pivotal patients frequency status release alginate clearance therapeutic imply infection dependent disruption finalized accordance iib february reported 2020 orphan treatment spirometry preparation medicinal 120 comprising antibiotics nda international model standardised exacerbations microbiology 35 approx demonstrated agency lung clinical ema

Project "OligoGpivotalCF" data sheet

The following table provides information about the project.

Coordinator	ALGIPHARMA AS Organization address address: INDUSTRIVEIEN 33 city: SANDVIKA postcode: 1337 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.
Coordinator Country	Norway [NO]
Project website	https://oligogpivotalcf.eu/
Total cost	12˙163˙748 €
EC max contribution	6˙013˙748 € (49%)
Programme	1. H2020-EU.3.1.3. (Treating and managing disease)
Code Call	H2020-SC1-2017-Two-Stage-RTD
Funding Scheme	RIA
Starting year	2018
Duration (year-month-day)	from 2018-01-01 to 2020-12-31

Partnership

Take a look of project's partnership.

#	participants	country	role	EC contrib. [€]
1	ALGIPHARMA AS ALGIPHARMA AS Organization address address: INDUSTRIVEIEN 33 city: SANDVIKA postcode: 1337 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.	NO (SANDVIKA)	coordinator	3˙224˙712.00
2	SMERUD MEDICAL RESEARCH INTERNATIONAL AS SMERUD MEDICAL RESEARCH INTERNATIONAL AS Organization address address: KARENSLYST ALLE 6 city: OSLO postcode: 278 website: www.smerud.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	NO (OSLO)	participant	2˙501˙250.00
3	KLINIKUM DER UNIVERSITAET ZU KOELN KLINIKUM DER UNIVERSITAET ZU KOELN Organization address address: Kerpener Strasse 62 city: KOELN postcode: 50937 website: www.uk-koeln.de contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (KOELN)	participant	123˙037.00
4	IMPERIAL COLLEGE OF SCIENCE TECHNOLOGY AND MEDICINE IMPERIAL COLLEGE OF SCIENCE TECHNOLOGY AND MEDICINE Organization address address: SOUTH KENSINGTON CAMPUS EXHIBITION ROAD city: LONDON postcode: SW7 2AZ website: http://www.imperial.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 (LONDON)	participant	79˙990.00
5	EUROPEAN CYSTIC FIBROSIS SOCIETY EUROPEAN CYSTIC FIBROSIS SOCIETY Organization address address: KASTANIEPARKEN 7 city: KARUP postcode: 7470 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.	DK (KARUP)	participant	52˙258.00
6	CYSTIC FIBROSIS EUROPE EV CYSTIC FIBROSIS EUROPE EV Organization address address: IN DEN DAUEN 6 city: BONN postcode: 53117 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.	DE (BONN)	participant	32˙500.00

Map

Project objective

The objective of the current proposal is to advance the orphan drug OligoG CF-5/20 (OligoG) through a pivotal phase IIb clinical trial, to enable a new and improved therapeutic approach for the orphan disease cystic fibrosis by 2020.

The study drug is an alginate oligosaccharide derived from seaweed. Several properties relevant to the treatment of CF have been demonstrated using in vitro and ex vivo model systems including release of stagnant mucus, disruption of bacterial biofilm and increased bacterial susceptibility to antibiotics. OligoG received an EU Orphan Drug Medicinal Product Designation in 2007 and an FDA Orphan Drug Designation February 2016, for the treatment of cystic fibrosis.

The planned clinical trial will include 120 CF patients from approx. 35 European sites in coordination with the European Clinical Trial Network. The final study design, selection criteria, procedures and endpoints will be based on results from a recently finalized phase II study and will follow scientific advice and protocol assistance sought at the European Medicines Agency (EMA). A set of clinical and exploratory endpoints will be defined to assess the various effects of OligoG, comprising lung function assessed by spirometry and Lung Clearance Index (LCI) measurements, infection status assessed by frequency of pulmonary exacerbations and non-culture-dependent microbiology, and patient reported outcomes assessed by questionnaires, including standardised CF questionnaires (CFQ-R).

A successful trial will enable preparation of international applications for conditional marketing authorisation (cMAA) throughout Europe and a New Drug Application (NDA) in the US, for the treatment of cystic fibrosis lung disease. In accordance with the work programme, a successful project will thus imply a new and improved therapeutic approach within cystic fibrosis available for CF patients by 2020.

Deliverables

List of deliverables.
Data Management Plan	Open Research Data Pilot	2019-07-23 17:23:33
Web-site launch - project communication	Websites, patent fillings, videos etc.	2019-05-31 16:32:41

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

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

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