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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 €

EC-Contrib. €

Partnership

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TT4CL project word cloud

Explore the words cloud of the TT4CL project. It provides you a very rough idea of what is the project "TT4CL" about.

multiple regulatory drug highlighted olpc regimens primary iran vivo shows anti regarded compounds poverty tropica advantages tropical disease parasite registration treatment pharmaceutical causing pharmacokinetic formulation structurally cutaneous species complete dosing pharmacodynamic leishmaniasis oleylphosphocholine rodent vitro stability doses guide fda climates priorities systemic carry indication orally optimize confirm country islamic cheap efficacy tablet miltefosine models appropriate stringent delivered synthesis parasites curative single subsequent clinical pharmacokinetics leishmanial animal oral sensitivity systemically tt4cl advantage cl release endemic republic implementing decisions active tolerability leishmania relationships

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 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.	UK (LONDON)	coordinator	1˙273˙863.00
2	AVIVIA BEHEER BV AVIVIA BEHEER BV Organization address address: TRANSISTORWEG 5 city: NIJMEGEN postcode: 6534AT 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.	NL (NIJMEGEN)	participant	591˙000.00
3	EBERHARD KARLS UNIVERSITAET TUEBINGEN EBERHARD KARLS UNIVERSITAET TUEBINGEN Organization address address: GESCHWISTER-SCHOLL-PLATZ city: TUEBINGEN postcode: 72074 website: www.uni-tuebingen.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 (TUEBINGEN)	participant	580˙150.00
4	LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE ROYAL CHARTER LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE ROYAL CHARTER Organization address address: KEPPEL STREET city: LONDON postcode: WC1E 7HT website: http://www.lshtm.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	569˙196.00
5	TEHRAN UNIVERSITY OF MEDICAL SCIENCES TEHRAN UNIVERSITY OF MEDICAL SCIENCES Organization address address: OFFICE OF VICE CHANCELLOR FOR GLOBAL STRATEGIES AN INTERNATIONAL AFFAIRS NO 21 DAMESHGH ST VALI E ASR AVE city: TEHRAN postcode: 1416753955 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.	IR (TEHRAN)	participant	371˙375.00
6	OBLITA THERAPEUTICS OBLITA THERAPEUTICS Organization address address: RODENDIJK 40 city: ZOERSEL postcode: 2980 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.	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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