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.
Chairman and CEO 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.”
Carol Olson, senior vice president of pharmaceutical development and chief medical officer of Immtech, said: “This evaluation will continue until patients stabilize or return to baseline status. At that time, Immtech and the independent experts in liver toxicity will prepare a summary of the available safety data and recommendations for presentation to the FDA. The clinical hold may be released after FDA has received satisfactory data regarding the safety of pafuramidine.”