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Biopharmaceutical therapy for treatment of Primary Hyperoxaluria

Objective

Interest in the use of naturally occurring human gut bacteria as pharmaceutical drugs has increased as knowledge about the human microbiota and its role in health and disease has advanced.
The ELIMOX project proposes to develop a new drug from Oxalobacter formigenes, an anaerobic bacterium whose only carbon source is oxalate, for the treatment of primary hyperoxaluria (PH). PH is a rare and life-threatening disease, present at birth, characterised by high endogenous levels of oxalate that damage the kidney and cause renal failure. Enteric elimination of oxalate via the gut provide an alternative elimination pathway for the oxalate and treatment with pharmacological doses of O. formigenes would facilitate such enteric elimination. The treatment employs a new approach whereby bacterial breakdown of excessive oxalate occurs in the gut, inducing an alternative pathway for the oxalate, thereby protecting the kidneys from failure. The O. formigenes approach to treat PH is an ideal model for bacterial treatment of metabolic disease.
The three SME participants will utilise the expertise of nine specialised research providers to increase the understanding of the characteristics of the sensitive, anaerobic and highly specialised O. formigenes, to implement the manufacturing process to obtain a clinically effective drug, to optimise drug delivery and to develop specialised analytical methods to monitor clinical effects following treatment. Technology advancements will be confirmed by clinical studies in PH patients and by mapping the presence of the bacteria before and after treatment with the O. formigenes drug.
The ELIMOX project will advance current standards and methodology in i) manufacture of anaerobic bacteria for pharmaceutical use, ii) identification, quantification and tracking of microbes in the human gut and their impact on human microbiota during treatment, iii) optimisation of tools to monitor clinical effects during treatment with anaerobic bacteria.

Call for proposal

FP7-SME-2013
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Coordinator

OXTHERA AB
Address
Sturegatan 56
11436 Stockholm
Sweden

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Elisabeth Lindner (Ms.)
EU contribution
€ 1 262 792

Participants (11)

COBRA BIOLOGICS LIMITED
United Kingdom
EU contribution
€ 579 199
Address
Stephenson Building The Science Park
ST5 5SP Keele

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Tracey Jane Macdonald (Mrs)
SYMBIO PHARM GMBH
Germany
EU contribution
€ 340 007
Address
Auf Den Luppen 10
35745 Herborn

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Kurt Zimmermann (Dr.)
ERGOMED CLINICAL RESEARCH LIMITED
United Kingdom
Address
Frederick Sanger Road - Surrey Research Park 26-28
Guildford

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Neil Clark (Mr.)
UNIVERSITATSKLINIKUM BONN
Germany
EU contribution
€ 2 000
Address
Venusberg-campus 1
53127 Bonn

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Bernd Hoppe (Prof.)
HOSPICES CIVILS DE LYON
France
EU contribution
€ 5 040
Address
Quai Des Celestins 3
69002 Lyon

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Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Odile Gelpi (Mrs)
UNIVERSITY COLLEGE LONDON HOSPITALSNHS FOUNDATION TRUST
United Kingdom
EU contribution
€ 1 960
Address
Euston Road 250
NW1 2PG London

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Activity type
Research Organisations
Administrative Contact
Gill Rumsby (Dr.)
GALENICA AB
Sweden
Address
Medeon Science Park
205 12 Malmo

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Christina Hallberg (Ms)
K.A.B.S. LABORATORIES INC. - KABS
Canada
Address
De Tonnanancour 4500
J3Y 9G2 St-hubert

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Jean-Simon Blais (Dr.)
MEDIZINISCHES VERSORGUNGSZENTRUM INSTITUT FUR MIKROOKOLOGIE GMBH
Germany
Address
Auf Den Luppen 8
35745 Herborn

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Andreas Schwiertz (Dr.)
NEDERLANDSE ORGANISATIE VOOR TOEGEPAST NATUURWETENSCHAPPELIJK ONDERZOEK TNO
Netherlands
Address
Anna Van Buerenplein 1
2595 DA Den Haag

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Activity type
Research Organisations
Administrative Contact
Marjorie Koenen (Dr.)
BIO-IMAGES RESEARCH LIMITED
United Kingdom
Address
Castle Street 84 Bio Imaging Centre Basement Medical Block Within Glasgow Royal Infirmary
G4 0SF Glasgow

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Lee Ann Hodges (Dr.)