TGN1412 episode Calls for Change in Drug Trials 

LONDON -- Britain's leading medical journal The Lancet called Friday for "urgent change" in the processes for approving and regulating human drug trials involving man-made antibodies, weeks after authorized tests left six men fighting for their lives.
The six men were hospitalized in Britain with severe side effects after volunteering to test the TGN1412, a monoclonal antibody, or a genetically engineered version of an antibody, which defends the immune system against infections

Five of the volunteers, the first humans to test TGN1412, have been released from the hospital. The sixth is no longer in critical condition and is improving, said Dr. Ganesh Suntharalingam, clinical director of intensive care at Northwick Hospital, in London.
The Lancet said that the MRHA's interim findings released earlier this month and saying there was no fault with either the drug or the testing procedures proved changes were needed.

Source: The Associated Press, April 14, 2006.

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