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JNCI Journal of the National Cancer Institute 2006 98(14):956-958; doi:10.1093/jnci/djj315
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© Oxford University Press 2006.

NEWS

Phase I Antibody Risks, Trial Safety Examined

Rabiya S. Tuma

The first 150 words of the full text of this article appear below.

Antibody therapies are the subject of discussion on both sides of the Atlantic this year. Britain and Germany are dealing with the serious fallout of a phase I trial this spring, and U.S. regulatory agencies are working to settle issues of dosing and treatment of antibody therapies in phase I trials.

The phase I trial, using a drug developed by the German company TeGenero AG, is part of a new wave of immune system–altering antibodies being developed to treat cancer and other ailments. More than 20 other antibody therapies have either been approved for use in humans or are in late-stage clinical development, yet many scientists view these new agents as riskier than traditional antibody therapies, which do not bind to immune system targets. Despite their concern, several scientists said the problem in the British trial, which put six people in the hospital, was likely with the TeGenero drug itself . . . [Full Text of this Article]

The British Trial

Antibodies and Oncology

FDA Addresses Phase I Antibodies


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