Immtech International, Inc. has initiated, in partnership with the University of North Carolina at Chapel Hill, a Phase III pivotal trial of its oral drug DB289 in the Democratic Republic of Congo to treat Trypanosomiasis (African sleeping sickness) and that it is screening patients for enrolment.
The study is planned at multiple sites in the Democratic Republic of Congo, New Sudan, and Angola. The Company plans to enrol approximately 250 "stage-one" patients in a randomized trial which will compare the effectiveness of DB289 to pentamidine, the current first line therapy in Africa which is difficult to administer in remote areas and is associated with significant side-effects.
Human African trypanosomiasis, also known as sleeping sickness, is caused by single-celled parasites, Trypanosoma brucei, which are transmitted to humans by infected tsetse flies. The illness produces fever, lymph node inflammation, eventual impairment of the brain and nervous system in its late stage and, if not treated, death. Stage-one patients are those infected with the African sleeping sickness parasites in their blood and lymph nodes. If untreated, the parasites will enter patients' cerebrospinal fluid and brain and cause a more severe form of the disease.
The trial is not blinded because DB289 is an oral drug and pentamidine is administered as an intramuscular injection.
The study protocol was reviewed and approved by the United States Food & Drug Administration as part of a Special Protocol Assessment. During the Phase III trial, the company intends to submit to the US FDA a treatment IND for approval which, if granted, would enable DB289 to be sold for the treatment of Trypanosomiasis in desperately ill patients while the clinical trials are being completed, according to a company release.
The World Health Organization estimates that there are 300,000 to 500,000 active cases of human African sleeping sickness in central Africa. A WHO survey reports that an "epidemic situation" for African sleeping sickness exists in the sub-Sahara region of Africa, which includes the countries of Angola, Sudan, Uganda and the Democratic Republic of the Congo and Georgia State University.