Trials are beginning on a new oral medication for a disease that threatens about 60 million people a year in 36 countries of sub-Saharan Africa.
An International research team is to commence clinical trials on a new treatment for trypanosomiasis, known as “Sleeping Sickness”.
The Phase III clinical trial starts this month. The new pivotal trial will involve approximately 250 patients in the Democratic Republic of the Congo and the Sudan. Angola will be included if a recent outbreak there of the Ebola-like Marburg virus remains under control.
The compound known as DB289 is the first new medication for the disease in 50 years, and the only oral medication that’s ever been developed. News of the trials was released by the University of North Carolina at Chapel Hill (UNC). UNC is the lead institution in the team which also includes researchers from Scotland, Kenya, England, and Switzerland.
Oral delivery of medication is important because the disease most frequently occurs in rural areas and villages not served by medical professionals capable of administering injections.
The Bill and Melinda Gates Foundation is supporting the work, led by Dr. Richard R. Tidwell, professor of pathology and laboratory medicine at the UNC School of Medicine.
There has been no research in this area by large pharmaceutical companies largely because of the lack of profit potential. A small pharmaceutical company, Immtech International is a contributor to this drug development effort.
“Despite being one of Africa’s most prevalent and economically devastating illnesses, sleeping sickness is definitely one of those that has been neglected,” Tidwell said. “For that reason, we decided to put this consortium together, and that’s why the Bill & Melinda Gates Foundation was very interested in supporting our work.”
DB289 has successfully undergone trials that have demonstrated its safety and effectiveness in patients with early-stage sleeping sickness. In the testing phase soon getting under way, scientists will give the treatment to hundreds of patients for the first time.
Sleeping sickness is passed from human to human by tsetse fly bites. The symptoms are fever, lymph node inflammation, impairment of the brain and nervous system in the late stages. It can lead to death without treatment.
The World Health Organization received reports of 45,000 cases of the disease in 1999. The agency says that most cases are occurring in areas where there is not reliable reporting on the occurrence of disease, and consequently estimates that the actual number of cases could be as much as 10 times higher.
Three years ago, the National Foundation for Infectious Diseases presented its Jimmy and Roselyn Carter Humanitarian Award to Bill and Melinda Gates. That day, a talk by former President Jimmy Carter about the work Roselyn and he did in Africa inspired Dr. Carol Olson, vice president and chief medical officer of Immtech, to work on deadly but neglected illnesses, she said.
Olson said “We have a real opportunity with DB289 and other drug candidates in the pipeline to help solve some very difficult health problems affecting millions of people in developing countries.”
