Immtech's pafuramidine program on hold

US A-based Immtech Pharmaceuticals says that it is working with clinical investigators at the South African site where a safety study is in progress for pafuramidine (DB289), an investigational therapy. In preliminary findings from the study, abnormal laboratory values were found in several volunteers following treatment with pafuramidine. The company has discussed the preliminary findings with the US Food and Drug Administration, and as a precautionary measure the pafuramidine program has been placed on clinical hold.

In this South African safety study volunteers were dosed with pafuramidine 100mg twice daily for 14 days or placebo. The subjects are undergoing close monitoring for any changes in the status of their liver function. No subject has required any treatment or hospitalization for the abnormalities to date.

The company's chief executive, Eric Sorkin stated: "our primary concern is the safety of the patients. We are working closely with experts and the Data Safety Monitoring Board for pafuramidine."