Immtech Pharmaceuticals, Inc. put on hold its clinical trial for pafuramidine, an experimental drug candidate to treat Pneumocystis pneumonia and African sleeping sickness.
Immtech was working with clinical investigators at one South African site where a single safety study is in progress for pafuramidine (DB289), an investigational therapy. In preliminary findings from this study, abnormal laboratory values were found in volunteers following treatment with pafuramidine. The company has discussed the preliminary findings with the US Food and Drug Administration (USFDA), and as a precautionary measure, the pafuramidine programme has been placed on clinical hold.
The clinical hold may be released after FDA has received satisfactory data regarding the safety of pafuramidine, said the company. Volunteers in this single South African safety study were either dosed with pafuramidine 100 mg 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.
"Our primary concern is the safety of the patients. We are working closely with independent experts and the Data Safety Monitoring Board for pafuramidine," said Eric L. Sorkin, chairman and chief executive officer, Immtech.
"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 study was planned in 2005, after discussions with US FDA, in order to provide a safety database of appropriate size for submission of these indications to regulatory authorities. These two diseases affect a relatively small number of patients (they are considered as orphan drug indications) and so there are fewer patients available than are generally required for Phase three trials. This study was designed to increase the number of subjects treated with pafuramidine.", said Carol Olson, M.D., Ph.D., senior vice president of pharmaceutical development and chief medical officer, Immtech.
After reviewing the available safety data and recommendations, BioAlliance Pharma will decide whether or not to go ahead with the product.
BioAlliance Pharma SA is a specialty pharmaceutical company focused on the treatment of opportunistic infections in cancer and HIV. The company develops and commercializes innovative products which address resistance issues.