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news.Immtech Pharmaceuticals has announced that it is working with clinical investigators at the South African site where a safety study is in progress for pafuramidine, 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 FDA, and as a precautionary measure the pafuramidine program has been placed on clinical hold.
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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.”