Immtech Announces Commencement of DB289 Formulation Trial

Immtech International has announced that enrollment was initiated for a Phase I volunteer human trial to evaluate two new formulations of DB289, its first oral drug candidate.

The study will compare the current capsule formulation to two new formulations of pressed tablets. The study of 42 healthy volunteers requires that each subject take a single 100-mg dose of each of the three formulations, with a seven day period between each dose. The study is being conducted in Florida.

Immtech expects it will take approximately seven weeks to complete the study, including enrollment, collection and analysis of the blood samples from the subjects and evaluation of the data. The three formulations are being evaluated to determine which has the most consistent absorption in the blood, and if there is a difference in the absorption of DB289 between the capsule and tablets. Tablets, which are lower in cost to manufacture, are more stable at high temperature and humidity and are preferred for drugs used in tropical climates.

The data will be used to select the best formulation for the pivotal Phase III studies in Trypanosomiasis and Pneumocystis pneumonia. In addition, Immtech reports that a contract manufacturing firm has completed the initial "scale-up" production of 10 kg of DB289 using a new manufacturing method. The company plans to validate this new method and begin the process of manufacturing the final validation batches in 2005. The validation batches are required as part of a new drug application to the FDA.