Immtech Initiates Malaria Treatment Trial

Immtech Pharmaceuticals has begun a Phase IIb clinical trial of its oral drug candidate pafuramidine maleate for treating uncomplicated malaria caused by Plasmodium falciparum.

This dose-ranging trial will involve doses of 400 or 600 mg, given either once or twice daily. Three days will be the treatment duration in the first stage of this trial. The primary objective is to establish a dose of pafuramidine that can be studied as monotherapy in a subsequent Phase III trial. The trial will also explore the efficacy of the combination of pafuramidine and artesunate as a treatment for malaria. Additionally, data from this trial will support Immtech's malaria prevention efforts. Currently Immtech is conducting a Phase II trial of pafuramidine for malaria prevention.

Pafuramidine 200 mg given twice daily for five days resulted in an excellent cure rate of 96 percent in Immtech's Phase IIa malaria treatment trial, setting a minimum effective dosage rate. Prior Phase II trials for malaria treatment were conducted with a capsule formulation of pafuramidine. This new trial will use the recently developed tablet formulation, which is expected to perform better in clinical practice.

In addition to the Phase IIa treatment trial, Immtech completed a Phase IIb clinical trial of pafuramidine to treat uncomplicated P. falciparum malaria in 120 patients in Thailand. The trial established a minimally effective dose, 100 mg twice daily for three days, which was one of the objectives of that trial.