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UK INDUSTRY CALLS FOR MORE STRICT CLINICAL TRIAL GUIDELINES

July 25, 2006

Britain's pharmaceutical industry has proposed strict new guidelines for testing some experimental drugs after the disastrous trial of TeGenero's TGN1412 in March that left six men in comas.

A report by the Association of the British Pharmaceutical Industry and the BioIndustry Association, industry's two largest trade associations, proposed that drugs that stimulate the immune system should be subject to more stringent safety standards when they are tested on humans for the first time.

The groups recommended that trials of these drugs should be staggered, with only one person receiving the drug on the first day. The report also said trials should only be carried out at hospitals with intensive care facilities able to deal with unforeseen problems.

German drugmaker TeGenero filed for bankruptcy protection earlier this month.