FDAnews Drug Daily Bulletin

TEGENERO FILES FOR BANKRUPTCY AFTER CATASTROPHIC CLINICAL TRIAL

July 7, 2006
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TeGenero, the German pharmaceutical startup whose UK-based clinical trial for its immune-boosting drug TGN1412 caused severe adverse reactions in six healthy male volunteers, has announced that it filed for bankruptcy protection in a court in Wurzburg, Germany, on July 4.

"The unforeseeable adverse reactions caused by TGN1412 in the TGN1412-HV Phase I trial have made it impossible to attract the investment necessary for the company to continue operations," the firm said in a statement.

The six affected participants fell ill on March 13, within hours of taking the investigational drug at the trial site at Northwick Park hospital in London. According to media reports, one of the trial participants, a trainee plumber named Ryan Wilson, is still confined to a wheelchair after suffering heart, liver and kidney failure, as well as pneumonia and septicemia.

TeGenero said that investigations conducted by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and Germany's Paul-Ehrlich-Institut "have identified no deficiencies" in the preclinical testing of the drug, and that the adverse events "were completely unforeseeable."

According to an April 6 statement from the German agency, "Low dosages of the trial medicine did not cause any adverse effects in the primates tested. Higher dosages caused only mild transient reactions. A very low dose, 1/160 of that used without adverse effects on monkeys, was used on humans." The MHRA said that the trial "was run according to the agreed protocol, and the correct dose of the product was given to the patients."

However, other reports indicated that the drug caused swollen glands in some of the test monkeys. One volunteer who received a placebo said the informed consent document was hard to read and he was pressured to sign it within 10 to 15 minutes.

The trial was conducted by the contract research organization Parexel, which cited the MHRA report on the trial in disclaiming responsibility. "Although there were certain discrepancies identified in the MHRA report, there were no issues that contributed to the adverse reactions experienced by the volunteers, despite the fact that this was a highly challenging situation," Herman Scholtz, head of Parexel International Clinical Pharmacology, said in a May 25 statement.

TeGenero said the trial participants' claims for compensation will continue to be handled by the firm's insurers. "TeGenero has been supporting the official investigations as well as developing laboratory tests of its own to try to establish what happened in the trial," the company said. "TeGenero will continue to make its expertise available for the purposes of such investigations to the fullest possible extent." (http://www.fdanews.com/did/5_131/)