Public Release:  $3 million awarded to find biomarkers for potential test of cure for chagas disease

Wellcome Trust to fund three-year study in Texas to look for new biological markers measuring treatment efficacy for the leading parasitic killer of the Americas

Drugs for Neglected Diseases Initiative

[Geneva, Switzerland; Atlanta, GA, USA - 12 November 2012] - Today at the 61st Annual Meeting of the American Society of Tropical Medicine and Hygiene (ASTMH), the Drugs for Neglected Diseases initiative (DNDi) announces a new $3 million Strategic Translation Award from the Wellcome Trust to identify new biological markers for the evaluation of treatment efficacy in Chagas disease, a potentially fatal neglected tropical disease.

Chagas disease infects approximately 8 million people worldwide and is the leading parasitic killer in the Americas, where it causes more deaths than malaria. There is currently no easy-to-use and reliable test available to assess if Chagas patients are rid of the parasite after treatment, and current treatment options have significant limitations due to poor safety, inconsistent efficacy, and long treatment duration. Determining if treatment has cured the infection requires difficult and lengthy repeat laboratory testing that can sometimes take decades due to the unique chronic nature of the disease. Patients and physicians are often skeptical of the benefit of treatment for the chronic, indeterminate form of Chagas without a direct way to measure cure. A new, robust test for the disease burden would help to expand treatment, as well as provide a valuable tool for accelerating the evaluation of new drugs in clinical trials.

The $3 million Wellcome Trust Award will fund the first-ever large-scale study involving treatment of non-human primates (macaques) naturally infected in their outdoor living environment with the parasite that causes Chagas disease, Trypanosoma cruzi. The animals will be treated with three drug regimens versus placebo: benznidazole at optimal dose, benznidazole at suboptimal dose, and another azole compound with anti-parasite activity. Over a period of 12 months after treatment, the animals will be examined for clearance of the Chagas parasite through polymerase chain reaction (PCR) and other blood tests. The primary goal of the study is to see if these blood tests can accurately measure parasitological cure.

"We need to be able to tell patients whether or not their treatment has worked," said Dr. Graeme Bilbe, Research and Development Director for DNDi. "The results of this study could encourage treating more patients now, with what we have, and facilitate future clinical trials of new treatments for chronic Chagas disease patients."

Initiated by Dr. John VandeBerg of the Texas Biomedical Research Institute (Texas Biomed; San Antonio, TX) and Dr. Rick Tarleton of the Center for Tropical and Emerging Global Diseases at the University of Georgia (Athens, GA), the study will be coordinated by DNDi with these partners and will begin within months and run until 2015. Texas Biomed will conduct the experimental protocols with the animals and conduct biomarker anlaysis, and the University of Georgia will also perform biomarker analysis. Other partners to perform some of the testing are the University of Texas at El Paso (UTEP; El Paso, TX), Gentris (Morrisville, NC), and the Argentinean National Council of Scientific and Technical Investigation (INGEBI-CONICET). To facilitate future biomarker discovery efforts, the biological samples collected in the study will be stored and made available to other researchers.

Today's announcement coincides with the first technical project meeting for this study taking place on November 12th at ASTMH's Annual Meeting in Atlanta.

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About Chagas disease

Chagas disease is endemic in 21 countries across Latin America, where it kills more people than any other parasite-borne disease, including malaria. It currently infects approximately 8 million people, kills an estimated 12,000 per year, and places 100 million people at risk. Chagas disease is a chronic, systemic, parasitic infection caused by the protozoan Trypanosoma cruzi. In 30-40% of cases, chronic Chagas disease will affect the heart and/or the digestive system. It is potentially fatal and a leading cause of heart failure in Latin America, resulting in frequent and prolonged hospitalization, use of pacemakers and defibrillators, and heart transplants. The disease causes loss of productivity among tens of thousands of young, working-age adults across Latin America, with over a billion dollars (USD) in estimated economic losses annually. As a result of worldwide population flow, Chagas disease is no longer confined to Latin America, with patient numbers growing in the United States, Europe, Australia, and Japan.

About DNDi

The Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit research and development organization working to deliver new treatments for neglected diseases, in particular sleeping sickness (human African trypanosomiasis), Chagas disease, leishmaniasis, specific helminth infections, malaria, and paediatric HIV. DNDi was established in 2003 by Médecins Sans Frontières/Doctors Without Borders (MSF), the Oswaldo Cruz Foundation (FIOCRUZ) of Brazil, the Indian Council of Medical Research (ICMR), the Kenya Medical Research Institute (KEMRI), the Ministry of Health of Malaysia, and the Pasteur Institute of France. The Special Programme for Tropical Disease Research (WHO/TDR) serves as permanent observer. DNDi currently has one lead drug candidate, E1224 (ravuconazole pro-drug), in clinical development for the treatment of Chagas disease, and two other drug classes in preclinical development.

Since its inception in 2003, DNDi has delivered six new treatments for neglected patients: two fixed-dose antimalarials (ASAQ and ASMQ), nifurtimox-eflornithine combination therapy (NECT) for late-stage sleeping sickness, sodium stibogluconate and paromomycin (SSG&PM) combination therapy for visceral leishmaniasis in Africa, a set of combination therapies for visceral leishmaniasis in Asia, and a paediatric dosage form of benznidazole for Chagas disease.

DNDi has helped establish three clinical research platforms: Leishmaniasis East Africa Platform (LEAP) in Kenya, Ethiopia, Sudan, and Uganda; the HAT Platform based in the Democratic Republic of Congo (DRC) for sleeping sickness; and the Chagas Clinical Research Platform in Latin America. Strong regional networks such as these help strengthen research and treatment-implementation capacity in neglected disease-endemic countries. www.dndi.org

About the Wellcome Trust

The Wellcome Trust is a global charitable foundation dedicated to achieving extraordinary improvements in human and animal health. It supports the brightest minds in biomedical research and the medical humanities. The Trust's breadth of support includes public engagement, education and the application of research to improve health. It is independent of both political and commercial interests. www.wellcome.ac.uk

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