RxTrials Institute Drug Pipeline Alert

French drugmaker BioAlliance Pharma will decide whether to continue studies with pafuramidine after Immtech Pharmaceutical halted its South African Phase III trial when abnormal laboratory values were found in volunteers at one site.

The study was evaluating the drug as a treatment for African sleeping sickness and Pneumocystis pneumonia, a fungal infection of the lungs in AIDS patients.

The hold may be released after the FDA has received satisfactory data regarding the safety of pafuramidine. Volunteers will be monitored for any changes in their liver function.

BioAlliance Pharma said it will make its decision after reviewing safety data. The company signed a licensing agreement with Immtech in December 2007 covering European commercialization rights to the drug to treat Pneumocystis pneumonia and to prevent malaria in travelers.