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A Phase I clinical trial in the U.K. has left six volunteers in an intensive care unit. Boston-based Parexel was running the trial for TGN 1412, an immunomodulatory monoclonal antibody being developed by the German biopharmaceutical company TeGenero for the treatment of autoimmune/inflammatory diseases and hematooncological malignancies. The trial was the first time the drug was used in humans. "Such an adverse reaction occurs extremely rarely, and this is an unfortunate and unusual situation," says Herman Scholtz, head of Parexel International Clinical Pharmacology. The patients are being treated at Northwick Park Hospital, where the trials were being conducted. The U.K.'s Medicines & Healthcare Products Regulatory Agency has suspended the trials and promises an "exhaustive investigation."
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