Pivotal Studies Begin for New Antimalarial in s...

LONDON and GENEVA, Switzerland, July 24 /PRNewswire/ --     Phase III studies 
have begun for a potential new antimalarial
treatment, chlorproguanil hydrochloride-dapsone-artesunate (CDA). The studies
will take place in a number of sites across sub-Saharan Africa to further
examine the safety and efficacy of treating acute, uncomplicated Plasmodium
falciparum malaria with CDA.



    CDA is being developed as a fixed-dose combination to meet the
urgent need for new malaria treatments in the developing world where
multi-drug resistance is contributing to an escalating health crisis. More
than 90 percent of the malaria cases and the great majority of deaths occur
in sub-Saharan Africa, where P. falciparum malaria is the most common 
form.(1) Currently, the Global Malaria Programme of the World Health 
Organisation (WHO) recommends that National Malaria Control Programmes use
artemisinin-based combination therapies (ACT) for the treatment of
uncomplicated malaria in the public sector.



Phase III Clinical Trial Programmes

    Two Phase III trials for CDA will involve almost 2,300
children, adolescents and adults. One study will evaluate CDA relative to
artemether/lumefantrine (Coartem(R)), currently the most widely registered
and used fixed-dose ACT for the treatment of P. falciparum malaria. This
study will measure the parasitological cure rate at 28 days, as well as
safety and parasite and fever clearance times.



    The second study will compare CDA's efficacy at 28 days to
that of Lapdap(TM). Lapdap is a fixed-dose combination pill containing two
well-established antimalarial agents, chlorproguanil and dapsone, which act
synergistically. The study will also determine the advantage of CDA over
Lapdap in terms of parasite clearance at 24 hours following the first dose.



    Commenting on the beginning of the Phase III trials, Dr. Chris
Hentschel, CEO of Medicines for Malaria Venture (MMV) said, "Moving into
Phase III trials marks a key step in the development of this promising
antimalarial. If proven safe and effective, CDA could become a major weapon
in the fight against drug-resistant malaria."



    CDA is being developed in collaboration between
GlaxoSmithKline (GSK), UNICEF/UNDP/World Bank, WHO Special Programme for
Research and Training in Tropical Diseases (WHO/TDR), and MMV. Academic
partners in its development are the University of Liverpool, Liverpool School
of Tropical Medicine and the London School of Hygiene & Tropical Medicine, as
well as clinical investigators across sub-Saharan Africa.



    Dr. Robert Ridley, Director of WHO/TDR, stated, "The
collaboration between WHO, MMV and GSK has been crucial in the development of
CDA, enabling resources and expertise to be shared and ultimately speeding
the development of this new antimalarial treatment." Dr. Lynn Marks, Senior
Vice President, Infectious Diseases Medicine Development Centre for GSK
added, "Working together in public-private partnerships, such as with CDA,
helps ensure that urgently needed new medicines are made available as quickly
and safely as possible."



    CDA will be studied using once-daily administration for three
days. Completing a full course of therapy is important to achieve parasite
clearance and minimize the potential for resistance development. If its
development is successful, CDA will be supplied at affordable, preferential
prices to the public sector in malaria-endemic developing countries to
maximise access for those in need.



    Approximately 40 percent of the world's population - mostly
those living in the poorest countries - are at risk of malaria.(2) The WHO
estimates that there are over 300 million new clinical cases of malaria
annually, directly causing over one million deaths.(2) Malaria kills one 
child every 30 seconds, and many children who survive an episode of cerebral
malaria suffer from learning impairments or brain damage.(2) Beyond the human
toll, malaria has a significant economic impact in endemic countries -
costing Africa US$12 billion in lost GDP every year and consuming 40 percent
of all public health spending.(3)



Notes to Editors:

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. GSK recognizes the importance of improved health for everyone in the
developing world and is the only major pharmaceutical company that is
developing treatments and vaccines for malaria, tuberculosis and HIV. GSK has
a dedicated group within its pharmaceutical R&D organisation which focuses on
diseases of the developing world and has also invested more than two decades
in the effort to develop a malaria vaccine. GSK was recently awarded the 2006
Frost & Sullivan Global Excellence Award in Malaria Prevention and Treatment
for its commitment to reducing the burden of malaria in developing countries.



    The GSK African Malaria Partnership supports behavior change
initiatives with Freedom from Hunger, the African Medical & Research
Foundation and Plan International. These programmes, which reach a combined
population approaching two million people, aim to raise awareness of malaria
and its transmission, promote protective measures such as use of
insecticide-treated mosquito nets and preventive treatment for pregnant
women, and encourage prompt treatment of malaria with effective medicines. In
addition, a new malaria advocacy initiative - Mobilising for Malaria, in
partnership with the Malaria Consortium, seeks to raise the profile of
malaria among politicians, the media and the general public in European and
African countries. 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 Organisation, 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.


    


    1. World Health Organisation TDR Malaria Fact Sheet. www.who.int/tdr
(Accessed June 2006)



    2. World Health Organisation Roll Back Malaria. What is Malaria?
Infosheet 1. www.who.int (Accessed June 2006)



    3. World Health Organisation Roll Back Malaria. Malaria in Africa
Infosheet 3. www.who.int (Accessed June 2006)



    Coartem(R) is a registered trademark of the Novartis Group, Novartis
International AG