Final results of the pivotal 500-patient Phase III clinical studies for artesunate/ mefloquine (AS/MQ) show that the new fixed-dose combination (FDC) is as effective as the existing separate tablet formulation – with a cure rate at day 63 of 94.1% vs. 92.0% respectively. A paediatric formulation for infants and children was also tested.

Both the new FDC and the existing separate tablet formulation have similar safety profiles, with low and comparable rates of minor side effects like: dizziness, lack of appetite, headaches and sleep disturbance. But the most commonly reported side effect for mefloquine – early vomiting, is lower for the FDC (3%) than for the separate tablet formulation (8.4%).

To improve patient compliance and to reduce risk of resistance, the new formulation will reduce adult treatment to 2 tablets once a day for 3 days, instead of 4 to 7 tablets per day in varying combinations for 3 days for the existing separate tablet formulation.

The Phase III study included infants, children, and adults and was conducted for DNDi in Thailand during the first 6 months of 2005 by the Shoklo Malaria Research Unit, part of the faculty of Tropical Medicine of Mahidol University, Thailand. The co-formulation has been developed by Far-Manguinhos in Brazil.

The Board will soon have a new member – DNDi’s patient representative. Paulina Tindana, Head of Communcations, Navrongo Health Centre, Navrongo, Ghana has been selected and will become an active member of DNDi’s Board from next year.

Simon Croft, R&D Director DNDi, Rob Ridley, Director TDR and member of the DNDi Board, and Alan Fairlamb, Professor of Biochemistry University of Dundee and member of DNDi’s Scientific Advisory Committee received the Kitasato Microbial Medal 2005 in “appreciation of their contribution to medicine”. Congratulations to them all!

A joint clinical study with MSF and Epicentre to test a simplified combination of nifurtimox and eflornithine (NECT) for 2nd stage sleeping sickness has started in Isangi, Democratic Republic of Congo; 27 patients have been recruited so far. This is the second of 5 sites of a multi-centre study involving DNDi, MSF, Epicentre, WHO/TDR and the national sleeping sickness control programmes of DRC, Congo-Brazzaville, and Uganda. DNDi will sponsor two more sites in DRC, which will start recruiting patients in early 2006. Two other sites are sponsored by MSF (Congo-B) and WHO/TDR (Uganda).

DNDi is collaborating with the Central Drug Research Institute (CDRI) Lucknow to test their library of compounds for activity against parasites that cause kala azar and sleeping sickness. Future collaborations are being planned with the Indian Institute of Chemical Biology (IICB), Kolkata, and the Indian Council of Medical Research (ICMR) on various projects in kala azar and malaria.

DNDi, in collaboration with the Swiss Tropical Institute (STI) and the Programme Nationale de Lutte Contre la Trypanosomiases Humaine Africane (Democratic Republic of Congo-DRC) organised a first strategy meeting for capacity building in clinical trials for human African trypanosomiasis (HAT/sleeping sickness) in August 2005 in Kinshasa, DRC. The aim was to bring together scientific and technical expertise in clinical trials for sleeping sickness and launch a HAT capacity building and strengthening platform in sub-Saharan Africa so that new and promising interventions for this fatal disease can be rapidly and effectively evaluated, registered, and made available to patients.
Over 35 scientists attended from Uganda, DRC, Republic of Congo, Sudan, Angola, as well as representatives of DNDi, WHO, Epicentre, STI, Institute of Tropical Medicine Antwerp, Malteser and Merlin, Kari Trypanosomiasis Research Centre, Find Diagnostics, Centers for Disease Control and Prevention, and Cooperation Technique Belgique. The key partners were enthusiastic about setting up sustainable clinical trials capacity for the region in the next year.