Drug Sends Six to the Hospital in Britain

By ROBERT BARR

LONDON – Two men were hospitalized in critical condition Wednesday and four others were in serious condition after suffering adverse reactions in trials of a new drug, and British regulators ordered the tests suspended.

Parexel International, which supervised the trial, identified the drug as TGN1412, a monoclonal antibody developed by TeGenero AG of Wuerzburg, Germany, for treatment of autoimmune and inflammatory diseases and leukemia.

Ganesh Suntharalingam, clinical director of intensive care at Northwick Park Hospital, said two of the men were in critical condition and four were in serious condition but showing signs of improvement.

"The drug, which is untested and therefore unused by doctors, has caused an inflammatory response which affects some organs of the body," Suntharalingam said.

The names of the six were not released.

"These events were completely unexpected and do not reflect the results we obtained from initial laboratory studies, which enabled us to progress investigations into human volunteers," TeGenero’s chief executive Dr. Benedikte Hatz said.

The clinical trial was performed by the research organization, Parexel International, based in Waltham, Mass., which "adhered to standard clinical research guidelines," said Dr. Thomas Hanke, the company’s chief scientific officer.

Parexel International has a clinical pharmacology research unit at the hospital.

"Such an adverse drug reaction occurs extremely rarely and this is an unfortunate and unusual situation," said Dr. Herman Scholtz, head of Parexel International Clinical Pharmacology.

The Medicines and Healthcare Products Regulatory Agency, which ordered the tests suspended, said the six were the only people given the drug in a small trial. Two other subjects received placebos.

"Our immediate priority has been to ensure that no further patients are harmed," said Kent Woods, the agency’s chief executive officer. "We will now undertake an exhaustive investigation to determine the cause and ensure all appropriate actions are taken."

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On the Net:

TeGenero AG, http://www.tegenero.com

Parexel International, http://nwww.parexel.com

Medicines and Healthcare Products Regulatory Agency, http://www.mhra.gov.uk