Parexel Drug Trial Had Shortfalls, U.K. Investigation Says
Parexel International Corp., which ran a clinical trial that left six men with multiple organ failure earlier this year, didn't have a doctor with adequate training and experience screening the patients, the U.K. health regulator said.
Parexel, based in Waltham, Massachusetts, failed to ensure that closely held German biotechnology company TeGenero AG, which developed the medicine, had proper insurance to cover the volunteers, the London-based Medicines and Healthcare products Regulatory Agency said today in an e-mailed statement.
TeGenero AG, a six-year-old biotech company based in Wuerzburg, Germany, developed the product, a laboratory-produced antibody designed to treat arthritis, leukemia and multiple sclerosis. It acts on a biological switch in the body's immune system that no drug had previously targeted, TeGenero said.
``We are satisfied that the adverse incidents which occurred were not as a result of any errors made in the manufacture of TGN1412, its formulation, dilution or administration to trial participants,'' Professor Kent Woods, MHRA Chief Executive Officer, said in the statement.
The six test subjects were hospitalized for several weeks after severe reactions to injections of the TeGenero medicine at a Parexel facility in north London on March 13.
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