LONDON (AP) – Six men participating in trials of a new drug to treat autoimmune diseases and leukemia were seriously ill in a London hospital after suffering adverse reactions, a hospital official said Wednesday. British regulators ordered an immediate suspension of the drug tests.

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. All six fell ill on Tuesday night.

Waltham, Mass.-based research organization Parexel International, which supervised the trial, identified the drug as TGN1412, a monoclonal antibody developed by TeGenero AG of Wuerzburg, Germany to treat autoimmune and inflammatory diseases and leukemia.

“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 men were not released. But one woman said her boyfriend, a 28-year-old London bar manager, was among them.

“They just keep saying he’s very, very sick and we are doing all we can,” Myfanwy Marshall told the British Broadcasting Corp. “They are saying he could be lying there in six months. He needs a miracle, those were their words.”

Marshall told the BBC her boyfriend had decided to participate in the trial for the cash – about $3,500 – to pay bills.

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.”

Dr. Herman Scholtz, head of Parexel International Clinical Pharmacology, said such adverse drug reactions are extremely rarely and it was an “unfortunate” situation.

“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.

Parexel International “adhered to standard clinical research guidelines,” said Dr. Thomas Hanke, the company’s chief scientific officer.

Hanke said TGN1412 had not caused any problems in previous testing and called for the investigation into the “shocking developments” to move quickly.


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AP-ES-03-15-06 1737EST

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