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Regulators: No Contamination in Drug Test

Posted on: Wednesday, 5 April 2006, 15:00 CDT

By THOMAS WAGNER

LONDON - Investigators have found no explanation for what went wrong in a clinical drug test which made six men seriously ill in Britain, regulators said Wednesday.

In an interim report, investigators said they found no evidence of product contamination or the use of improper practices in last month's trial of TGN1412, a drug being tested for treatment of leukemia and autoimmune and inflammatory diseases. Investigators will appoint a panel to make recommendations on how drugs like this can be safely developed in the future.

"The group will need to review the evidence from the TGN1412 case and consider what necessary changes to clinic trials may be required," Kent Woods, chief executive of the Medicines and Healthcare products Regulatory Agency, or MHRA, said at a news conference.

The six healthy volunteers, who were each paid 2,000 pounds ($3,500) for taking part in the trial, suffered convulsions and organ failure after being given trial doses of TGN1412. All but one of the six have left the hospital, officials said.

The MHRA said the drug was not contaminated or "contained anything other than the correct ingredients." The agency also found nothing in the way the trial was run that may have contributed to the reactions.

Woods dismissed suggestions that there were errors in the timing of the doses given to the volunteers or questions over why all six men were given the drug at the same time. He said the dose - 500 times lower than that given to animals - should have provided a safety margin.

The agency said the effects in people had not been seen "in preclinical tests in animals at much higher doses."

The trial of the monoclonal antibody developed by TeGenero AG of Wuerzburg, Germany, was being run at a London hospital by Waltham, Mass.-based Parexel International Corp.

TeGenero initially said there had been no "drug-related adverse events" in tests on animals, but later acknowledged the drug had left monkeys with swollen glands.

About 350 similar phase one clinical trials on humans are conducted every year in Britain - tests which will continue pending further investigation.

"There's no simple explanation of what happened," Woods said.

The MHRA said its findings raised questions about the potential risk involved in human trials. It said TGN1412 was a new class of monoclonal antibody which had a stimulatory action affecting cells in the immune system.

"This is a complex scientific issue which raises important scientific and medical questions about the potential risks associated with this type of drug and how to make the transition from preclinical testing to trials in humans," the agency said.

British Health Minister Norman Warner said, "Clinical trials in general have an excellent safety record, but it is vital we learn lessons from this incident to avoid any similar situations in the future." The investigative panel of British and international experts is expected to report its findings to the government in three months.

"This is an interim report that nothing untoward has happened in the mechanics of the trial or the manufacturing process of the drug," Dr. David Chiswell, the founder and former chief executive officer of Cambridge-based Cambridge Antibody Technology Group PLC, a leading developer of human monoclonal antibodies, said.

"It remains to be seen whether a full understanding of the biological effects of the antibody in all of the species tested would help prevent this sort of terrible reaction happening again," he said.

Chiswell and Cambridge Antibody Technology had no connection with TGN1412 or the MHRA probe.

Source: Associated Press/AP Online

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