COMPANY LAUNCHES STUDY OF DRUG FOR AFRICAN SLEEPING SICKNESS

Immtech Pharmaceuticals announced it has completed enrollment in a Phase III trial of its oral drug candidate to treat first-stage trypanosomiasis, also known as African sleeping sickness.

African sleeping sickness is caused by a protozoan parasitic disease spread by tsetse flies in sub-Saharan Africa, according to the company. It occurs in 36 countries of sub-Saharan Africa, where approximately 60 million people are at risk.

The trial is being conducted in six clinical sites in the Democratic Republic of Congo, Angola and Sudan and includes approximately 250 first-stage patients. The objective of this randomized, comparative trial is to assess the efficacy, safety and tolerability of pafuramidine maleate, the candidate drug, and pentamidine, the current standard therapy for African sleeping sickness. Half of the study patients will receive pafuramidine twice daily for 10 days and the other half receive once-daily injections of pentamidine for seven days. Patients will be monitored for clearance of the parasite at specified intervals for 24 months after the treatment regimen is completed.

Because of the favorable preclinical safety data for pafuramidine in reproductive and juvenile animals, the FDA allowed pregnant women and adolescents to be enrolled in this trial. Pregnant women and children are known to be especially vulnerable to African sleeping sickness.

Upon approval, the company plans to apply with the World Health Organization (WHO) to have the pafuramidine designated a WHO-recommended drug, so that it could be made widely available in developing countries.