Drug trial fiasco company goes bankrupt

The German company says that the unforeseeable adverse reactions caused by its monoclonal antibody TGN1412 in the Phase I safety trial have made it impossible to attract the investment necessary to continue operations.

“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,” the company said in a statement.

The news comes a week after the most seriously affected volunteer, Ryan Wilson, aged 20, left Northwick Park Hospital in London following four months of treatment. Wilson is using a wheelchair, and will need surgery to remove toes and finger ends.

Noting that the UK regulator, the MHRA, and the German investigator, the Paul Ehrlich Institute, found no shortcomings in the pre-clinical testing of TGN1412 by TeGenero, the company said, “The unpredictability of such effects, presents a major challenge for the industry if it is to develop this kind of innovative and powerful treatment and we regret that our company will not be able to continue working to find a solution in the present scope.”

Following the filing for insolvency, the company’s assets and its management will be supervised, in accordance with German rules, by an interim-insolvency receiver until insolvency procedures have been initiated by the relevant court.

The timing of the insolvency is dictated by German law, but it raises concerns for the compensation claims of the six affected volunteers. TeGenero said the legal representatives of the volunteers have been informed that it has filed for insolvency, adding the claims would continue to be handled by its insurers.

The company said it has been supporting the official investigations into what went wrong in the trial, as well as developing laboratory tests of its own to try to establish what happened, and will continue to make its expertise available.