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FRANKFURT, Germany (AP) – German drugmaker TeGenero AG filed for bankruptcy Tuesday, saying it was unable to attract investors after a drug trial in Britain that left six healthy volunteers fighting for their lives.

The company said in a statement that it filed for insolvency at a court in the Bavarian city of Wuerzberg, where it is based, due to the fallout from the widely publicized drug trial in March.

Six volunteers took part in a trial for the test drug TGN1412, designed to treat autoimmune and inflammatory diseases and leukemia. Within hours of being given doses of the drug, they suffered convulsions and organ failure.

The company said that the bankruptcy filing would not affect the six men’s efforts to claim damages, adding that its insurers were overseeing the claims.

“The unforeseeable adverse reactions caused by TGN1412 in the TGN1412-HV phase 1 trial have made it impossible to attract the investment necessary for the company to continue operations,” TeGenero said.

“The adverse events suffered by the volunteers in the TGN1412-HV trial were personally devastating for everyone at the company, dedicated as they are to the development of medicines which are intended to help people with serious disease conditions,” TeGenero said.

The trial of the monoclonal antibody developed by TeGenero 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.

The most seriously affected volunteer, Ryan Wilson, 21, was released from a hospital in London last week. He has been told parts of his fingers and toes will have to be amputated after he developed gangrene.

Wilson and the five others were each paid 2,200 pounds (about $3,500; 2,900 euros) for taking part in the trial.

British drug regulators criticized Parexel in May for failing to follow several trial procedures, including keeping proper patient records, ensuring 24-hour medical cover and checking insurance, according to the final report into the trial by Britain’s Medicines and Healthcare products Regulatory Agency, or MHRA.

TeGenero said that no further human testing of TGN1412-HV “would be possible without identifying the causes of the adverse reactions experienced by the volunteers.”

Four of the men involved in the trial received unconditional compensation payments of 10,000 pounds from Tegenero. Lawyers are awaiting the results of medical tests on the individuals before making specific compensation claims.

In its filing, TeGenero listed the TGN drug as an asset. The company statement did not list other assets or liabilities.



On the Net:

http://www.tegenero.com

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