Public Release: 

New antimalarial combination confirms its potential use in treating drug-resistant malaria

Phase III trials planned to confirm its efficacy and capability for widespread use in Africa

Burness

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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Notes to Editors:

Incidence of Malaria
The World Health Organization estimates that there are 300 million malaria cases annually, directly causing one million deaths and directly contributing to a further 1.7 million deaths.2 Malaria kills one child every 30 seconds and is the leading cause of death in young children in Africa.2 Hundreds of millions of African children and adults are chronically infected with malaria. Between 30 and 50 percent of inpatient admissions and half of all outpatient visits are attributed to malaria each year.3 Beyond the human toll, malaria has significant economic impacts in the endemic countries - costing Africa US$12 billion in lost GDP every year and consuming 40 percent of all public health spending.3

About GSK
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, visit GlaxoSmithKline on the World Wide Web at www.gsk.com.

About MMV
Medicines for Malaria Venture (MMV) is a non-profit organisation dedicated to reducing the burden of malaria in disease-endemic countries by discovering, developing and delivering new affordable antimalarials through effective public-private partnership. After five years of operation, MMV is managing the largest-ever portfolio of malaria drug research with more than 20 projects in different stages of drug research and development. MMV's goal is to register at least one new antimalarial before 2010 and maintain a sustainable pipeline of antimalarials to meet the needs of the 2.4 billion people at risk of this deadly disease. For further information please consult www.mmv.org.

About WHO/TDR
The Special Programme for Research and Training in Tropical Diseases (TDR) is a global program of scientific collaboration established in 1975, sponsored by the World Health Organization, World Bank, United Nations Development Programme and United Nations Children's Fund, and based in Geneva, Switzerland. Its focus is research into neglected diseases of the poor, with the goal of improving existing approaches and developing new ways to prevent, diagnose, treat and control these diseases. For more information, visit them online at www.who.int/tdr.

For further information and interview requests:

MMV Enquiries
Anna Wang Tel: +41 22 799 4078
Communication and Advocacy Officer Tel: +41 79 204 2875 (mobile)

WHO/TDR Enquiries
Jamie Guth Tel: +41 22 791 1538
Tel: +41 79 441 2289 (mobile)

GlaxoSmithKline Enquiries
Robin Fastenau
Product Public Relations Tel: +1 919 483 7966

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1. Wootton D, Opara H, Dube-Mbeye Q et al. A dose-ranging, phase II trial of chlorproguanil-dapsone with 3 doses of artesunate for the treatment of acute uncomplicated Plasmodium falciparum malaria. Poster presented at the 4th MIM Pan-African Malaria Conference; 14-18th November 2005; Cameroon.
2. World Health Organisation Roll Back Malaria. What is Malaria? Infosheet 1. www.who.int. (Accessed Apr 2005)
3. World Health Organisation Roll Back Malaria. Malaria in Africa Infosheet 3. www.who.int. (Accessed Apr 2005)

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