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European Biopharmaceutical Review

The Legal Implications of Phase I Clinical Trials

Anthony Warnock-Smith, Partner and Head of the life sciences group at the London office of Morgan Lewis examines the future role of Phase I clinical trials in the light of the recent disastrous TeGenero experience

Phase I clinical studies in healthy volunteers are, from a legal perspective, inherently problematic – a fact that was illustrated recently by the lifethreatening side-effects experienced by the six healthy volunteers who took part in the now infamous TeGenero Phase I trial of its monoclonal antibody product, TGN1412.

Phase I studies are never without risk, largely because the medicine being tested has, at that stage, only been tested theoretically and in animals. Despite this, there has only been a small level of personal injury among Phase I volunteers since current legal and clinical practice procedures were introduced in the 1970s, including just one recorded death.

The severe reactions of the volunteers in the TeGenero trial are thought to have occurred because the type of drug being tested – a monoclonal antibody which is a form of biological medicine – was designed explicitly to target a specific human protein. The prior animal tests that were conducted using the drug revealed no drug-related adverse events, probably because the artificial antibodies in the drug were designed to latch onto human protein only.

The failure of TGN1412 is a significant blow for what has been regarded as one of the most promising sub-categories of the relatively new monoclonal antibody class of drugs, and could have negative implications for development within this drug category, which is thought to show potential in the treatment of diseases such as cancer, immune and inflammatory disorders. Beyond the potential set-back of this sub-category, the TeGenero incident is likely to have even greater consequences for clinical trials in general, because it has caused the pharmaceutical industry and the regulatory authorities in the EU to revisit the safeguards put in place for Phase I studies.


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Anthony Warnock-Smith, Partner and Head of the life sciences group at the London office of Morgan Lewis examines the future role of Phase I clinical trials in the light of the recent disastrous TeGenero experience
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