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UK drug trial effects were 'unpredicted'

Preliminary report suggests neither manufacturing nor dosing issues were to blame for reactions to monoclonal antibody TGN1412

Alison McCook
Neither the manufacturing process nor problems in dosing or study protocol were to blame for the violent reactions that felled six healthy volunteers last month who took a new monoclonal antibody designed to treat autoimmune disease and leukemia, according to an interim report from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) released Wednesday (April 5). Instead, the report suggests that an ?unpredicted biological action of the drug? caused the reactions in humans.?If these findings were to be confirmed, it would indicate that this product showed a pharmacological effect in man which was not seen in pre-clinical tests in animals at much higher doses,? MHRA?s chief executive professor Kent Woods said in a statement.The report said that an independent group of experts plans to look further into the evidence from the investigation, and consider whether there should be sweeping changes in how clinical trials are carried out, specifically those...

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