Patient screening underway for Pyramax® sub-study in Sotuba, Mali

This WANECAM antimalarials study is mainly funded by EDCTP, and co-funded by MMV

09 Nov 2011

The West African Network for Clinical Trials of Antimalarial Drugs (WANECAM) started screening patients at a clinical trial site in Sotuba near Bamako, Mali, for its pyronaridine-artesunate sub-study on 24 October 2011. Pyramax® is provided by Shin Poong Pharmaceutical Company Ltd (South Korea). The start of patient recruitment is an important milestone in the project that aims to assess the safety and efficacy of repeated treatment with different Artemisinin-based combination treatments (ACTs) over a period of two years in children and adults suffering from uncomplicated malaria.

New antimalarial Pyramax®
Pyronaridine-artesunate (Pyramax®) has already proved to be a very promising new antimalarial treatment. Pyramax® is developed by Shin Poong in collaboration with Medicines for Malaria Venture (MMV). The candidate medicine has completed a series of clinical trials in South East Asia and Africa demonstrating more than 95% efficacy at day 28. The drug study dossier was submitted to the European Medicines Agency in March 2010. The request for regulatory approval is for a dual indication against Plasmodium falciparum and blood stages of Plasmodium vivax malaria. Pyramax® has been approved by the Korean Food and Drug Administration (KFDA) on 17 August 2011.
 
WANECAM project
The project, coordinated by Dr Abdoulaye Djimdé, Associate Professor and Head of the Molecular Epidemiology and Drug Resistance Unit of the University of Bamako (Mali), compares safety and efficacy of two new candidate antimalarial drugs with that of the existing ACTs that are the standard treatment in the region. This is part of the WANECAM trial, a phase IIIb/IV randomised, multi-centre, open label, parallel, 3-arm clinical study assessing the safety and efficacy of repeated administration of pyronaridine-artesunate (PA), dihydroartemisinin-piperaquine (DHA-PQP) or artemether-lumefantrine (AL) or artesunate-amodiaquine (ASAQ). The total number of patients being randomized in each study arm will be 1344. The study involves sites in Mali, Burkina Faso and the Republic of Guinea, and is expected to be concluded in 2014.

Moreover, this EDCTP project integrates capacity development in the conduct of the trial and aims to develop the regional (Burkina Faso, Mali and Guinea) capacity to execute state of the art clinical trials. It provides for improvement of research infrastructure, development of research collaboration and training of medical and research staff, including three PhD and three Masters students.   

Partnership
Besides the clinical trial sites, a large number of research institutions contribute to this study: the University of Bamako & Malaria Research and Training Centre, Bamako (Mali); the Centre National de Recherche et de Formation sur le Paludisme (CNRFP), Ouagadougou (Burkina Faso); the Institut de recherche en sciences de la santé (IRSS), Bobo-Dioulasso (Burkina Faso), the Centre National de Formation et de Recherche en Santé Rurale (CNFRSR) de Mafèrinyah, Conakry (Republic of Guinea), the Medical Research Council (MRC) Gambia, Fajara (The Gambia), University of Heidelberg (Germany), the Université Claude Bernard Lyon 1, Lyon (France), the Karolinska University Hospital, Stockholm (Sweden); and the London School of Hygiene & Tropical Medicine (LSHTM), London (UK).

Additionally, four pharmaceutical companies are contributing to the project: Novartis, Sanofi, Sigma-Tau, and Shin Poong Pharmaceutical Company Ltd.

The study is mainly funded by EDCTP, and co-funded by Medicines for Malaria Venture (MMV), MRC (UK), SIDA (Sweden); the German Ministry for Education and Research (BMBF, Germany), the University Claude Bernard (Lyon, France); MRTC (Mali), CNRFP (Burkina Faso), IRSS (Burkina Faso), and CNFRSR (Republic of Guinea)

More information
See also earlier safety and efficacy results from another Phase III study funded by MMV and Shin Poong, published in The Lancet, vol. 375, issue 9742, 1457-1467, 24 April 2010
The clinical trial is registered at the Pan African Clinical Trials registry under number: PACTR201105000286876