Phase III trials planned to confirm its efficacy and capability for widespread use in Africa
Yaoundé, Cameroon, 15th November 2005 – Clinical results demonstrating the potential benefits of treating Plasmodium falciparum malaria with a new artemisinin-based combination therapy (ACT), chlorproguanil hydrochloride-dapsone-artesunate (CDA)1, were announced today at the 4th Multilateral Initiative on Malaria (MIM) Pan-African Conference in Cameroon. CDA is being developed to meet the urgent need for new malaria treatments for Africa where drug resistance is contributing to an escalating health crisis. Dr. Arata Kochi, Director of the WHO Roll Back Malaria (RBM) Department stated, "The effort to develop CDA responds to RBM's call for fixed-dose artemisinin containing combinations."
The phase II trial of CDA, involving adults and children with P. falciparum malaria, was designed to determine the optimum dose of artesunate in combination with LapdapTM (chlorproguanil/dapsone). Treatment with CDA, at three doses of artesunate (1, 2 and 4mg/kg) in adults and at two doses (2 and 4mg/kg) in children, led to faster time to reduce parasite levels in the blood by 90 percent when compared to treatment with Lapdap alone.1 Reductions in parasite viability and potential parasite reproductive ability in patients were also greater in those treated with CDA than Lapdap alone. All treatment doses of CDA were generally well tolerated, and the nature and incidence of adverse events were similar across treatment groups.1
"These results suggest that CDA could become a major weapon in the fight against drug-resistant malaria. Moving into phase III trials marks a key step in the development of this promising antimalarial," commented Dr. Chris Hentschel, CEO of MMV.
Phase III trials for CDA are planned across sub-Saharan Africa and will further study the safety and efficacy of treating P. falciparum malaria with CDA. One study will compare CDA against the only fixed-dose ACT currently available for the treatment of P. falciparum, artemether/lumefantrine, over a three-day treatment period; and a second study will compare CDA to Lapdap alone. If the development of CDA is successful, it is expected to be available in 2008 as a convenient, once-daily dose. CDA will be made available to the public sector of malaria-endemic countries at preferential prices in order to maximise its availability to those in need.
CDA is being developed in collaboration with GlaxoSmithKline (GSK), the World Health Organization's Special Programme for Research and Training in Tropical Diseases (WHO/TDR), Medicines for Malaria Venture (MMV), the University of Liverpool, Liverpool School of Tropical Medicine and the London School of Hygiene & Tropical Medicine.
Dr. Robert Ridley, Director of WHO/TDR, stated, "The collaboration between WHO/TDR, MMV, GSK and our academic partners has enabled us to combine resources and expertise to speed the development of CDA."
"GSK is committed to research and development into treatments for diseases of the developing world," said Dr. Lynn Marks, Senior Vice President, Infectious Diseases Medicine Development Centre for GSK. "Public-private partnerships, such as this one for CDA, are vital in ensuring that urgently needed medicines are made available as quickly and safely as possible."
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