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TT4CL SIGNED

Clinical development of oral oleylphosphocholine as a new drug for the treatment of Old World Cutaneous Leishmaniasis

Total Cost €

0

EC-Contrib. €

0

Partnership

0

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Project "TT4CL" data sheet

The following table provides information about the project.

Coordinator
ST GEORGE'S HOSPITAL MEDICAL SCHOOL 

Organization address
address: CRANMER TERRACE
city: LONDON
postcode: SW17 0RE
website: http://www.sgul.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.

 Coordinator Country United Kingdom [UK]
 Total cost 0 €
 EC max contribution 3˙753˙135 € (0%)
 Programme 1. H2020-EU.3.1.3. (Treating and managing disease)
 Code Call H2020-SC1-2018-Two-Stage-RTD
 Funding Scheme RIA-LS
 Starting year 2019
 Duration (year-month-day) from 2019-05-01   to  2023-04-30

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    ST GEORGE'S HOSPITAL MEDICAL SCHOOL UK (LONDON) coordinator 1˙273˙863.00
2    AVIVIA BEHEER BV NL (NIJMEGEN) participant 591˙000.00
3    EBERHARD KARLS UNIVERSITAET TUEBINGEN DE (TUEBINGEN) participant 580˙150.00
4    LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE ROYAL CHARTER UK (LONDON) participant 569˙196.00
5    TEHRAN UNIVERSITY OF MEDICAL SCIENCES IR (TEHRAN) participant 371˙375.00
6    OBLITA THERAPEUTICS BE (ZOERSEL) participant 367˙550.00

Map

 Project objective

Cutaneous leishmaniasis (CL) is a poverty related, neglected tropical disease, which is without an effective and cheap systemic treatment. The aim of TT4CL is to develop a new orally available drug for treatment of CL aimed towards registration with stringent regulatory authorities. Oleylphosphocholine (OlPC), regarded as a new drug by the FDA, is structurally related to the anti-leishmanial miltefosine. It is being developed as an immediate-release tablet for the treatment of CL and, currently, is the only systemically delivered drug specifically being developed for this indication. OlPC is active in vitro and in vivo against different CL-causing Leishmania parasite species and shows curative advantage over miltefosine in rodent models of leishmaniasis. The primary objective of this study is to complete the pre-clinical package that is essential for the subsequent clinical development of OlPC. The project will aim to optimize the synthesis and formulation of OlPC, including stability testing that is appropriate for tropical climates. It will include in vitro drug sensitivity analyses in parasites causing CL (Leishmania tropica and L. major) in the Islamic Republic of Iran, with our endemic-country partner. Comparative studies in animal models with existing anti-leishmanial compounds will establish efficacy advantages and determine pharmacokinetic-pharmacodynamic relationships for OlPC. Phase 1 studies will confirm tolerability and pharmacokinetics of single doses and multiple dosing regimens. Results will be used to guide decisions by future partners on the clinical development of OlPC. This proposal directly addresses the priorities highlighted in this H2020 call. To our knowledge, we are the only consortium that is implementing this type of approach, and there is no other interest in the pharmaceutical sector to carry out a development programme for the oral treatment of CL.

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The information about "TT4CL" are provided by the European Opendata Portal: CORDIS opendata.

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lastchecktime (2021-05-17 3:18:30) correctly updated