Parexel's TGN 1412 drug trial suspended

A UK trial of a drug candidate which is being developed for the treatment of rheumatoid arthritis and leukemia has been suspended after six of its eight subjects became critically ill and were admitted to the intensive care unit of Northwick Park Hospital in London. The two unaffected study subjects had been given placebo. The compound, known as TGN 1412, is a humanized monoclonal antibody designed to treat a wide range of immunological disorders, and is being developed by German drugmaker TeGenero AG utilizing an active ingredient manufactured by Boehringer Ingelheim.

The trial, which was being conducted on TeGenero's behalf by US study specialists Parexel, had only been initiated in the UK so far, although the firm does have permission to begin assessment of the compound in Germany. The UK's Medicines and Healthcare products Regulatory Authority has halted the program and begun an investigation of the incident in collaboration with the Department of Health and the Metropolitan police.

Parexel said that the volunteers had suffered an "adverse drug reaction" that was not expected and did not reflect the initial results of laboratory studies, while TeGenero's chief executive Benedikte Hatz said that "the clinical trial performed by Parexel adhered to standard clinical research guidelines." For its part, Boehringer Ingelheim said it had no responsibility for the study as it had only carried out contract manufacturing work to TeGenero's specifications, adding that it regretted the adverse effects.