Immtech International Inc. announced that all 30 patients participating in the concluded phase IIb extended dose regimen arm of its clinical trial of DB289 for treating African sleeping sickness (Trypanosomiasis) cleared the parasite that causes African sleeping sickness within the treatment period, with no significant adverse results reported.
This arm of the open label trial used DB289 as treatment twice per day (100 mg each dose) for ten days. The medical investigators will continue to monitor the patients for re-occurrence of the disease at 3, 6, and 12 months. The study was conducted at two sites in the Democratic Republic of the Congo-Maluku (located near the capital Kinshasa) and Vanga (centrally located in the country), Immtech International said here.
T Stephen Thompson, president and CEO of Immtech, said, "We are pleased with the preliminary results of this study, which will be incorporated in the upcoming randomized open label phase III pivotal study to be conducted at multiple sites in Angola and the Democratic Republic of Congo."
The World Health Organization estimates that there are 500,000 to 750,000 active cases of human Trypanosomiasis in central Africa and another 60 million people that are at risk of contracting the disease. A World Health Organization survey suggests that an "epidemic situation" for Trypanosomiasis exists in the sub-Sahara region of Africa. Epidemic levels are also being approached in Angola, Sudan, Uganda and the Democratic Republic of the Congo. Trypanosomiasis is fatal if left untreated.
Immtech International Inc. is a pharmaceutical company advancing the development and commercialization of oral drugs to treat infectious diseases and neoplastic (cancer) and metabolic (diabetes) disorders.