LONDON - German biotechnology company TeGenero AG, which made a drug that left six men - including a New Zealander - seriously ill when a clinical trial went badly wrong in Britain earlier this year, has filed for insolvency.
Privately owned TeGenero submitted the filing in the Bavarian city
of Wuerzburg after failing to attract investment necessary for the company to continue operating, it said in a statement.
Six healthy volunteers took part in the clinical trial at a hospital in north London in March to test TeGenero's drug, TGN 1412, which was designed to treat chronic inflammatory conditions and leukaemia.
"The unforeseeable adverse reactions caused by TGN 1412 in the TGN 1412-HV Phase I trial have made it impossible to attract the investment necessary for the company to continue operations," TeGenero said.
The group said that claims for compensation would continue to be handled by its insurers, but lawyers for the trial volunteers expressed concern.
Martyn Day, a solicitor representing four of the men, said his clients were "deeply shocked" by the news, in particular as it came shortly before they were expecting to hear about the outcome of medical tests.
"This has massively added to their fears for the future," Day told Reuters. "It is going to greatly add to their fears of being able to get proper compensation."
The clinical trial was run in Britain by US drug research company Parexel International Corp. on behalf of TeGenero.
British regulators concluded, after studying the evidence, that the drug appeared to cause an unprecedented biological reaction in humans, which was not seen in animals. It had previously been tested on rabbits and monkeys.
Regulators criticised Parexel for not following certain recommended trial procedures, including keeping proper patient records, but said the severe reaction was not due to errors in how the drug was made or tested.
TGN 1412 belongs to a class of drugs known as monoclonal antibodies, which specifically bind to target molecules. TGN 1412 targets and activates an immune system protein called CD28.
- REUTERS
