TeGenero AG, (WURZBURG, Germany), a privately held biopharmaceutical company, has filed for the commencement of insolvency proceedings at the competent local court/insolvency court because the serious adverse reactions caused by the investigational agent TGN1412 in the March 2006, first-in-man, phase I trial made it impossible to attract the investment necessary for the company to continue operations. TeGenero's development portfolio including TGN1412 will be treated as an asset of the company, although no additional clinical trials would be possible without identifying the causes of the serious adverse reactions experienced by the healthy volunteers in this phase I trial.

All six subjects dosed with TeGenero's study drug experienced massive inflammatory responses forcing an immediate suspension of the trial as ordered by British regulators from the Medicines and Healthcare Products Regulatory Agency (MHRA). The most seriously affected volunteer was recently released from a hospital following a 3-month stay and will likely require surgery due to the occurrence of gangrene.

TGN1412 (CD28-SuperMABR) is an immunomodulatory, fully humanized, superagonistic, anti-CD28 monoclonal antibody under development for the treatment of autoimmune and inflammatory diseases such as rheumatoid arthritis and multiple sclerosis, and certain cancers such as leukemia. The MHRA, the UK regulatory authority responsible for clinical trial approval, in its interim report found that the serious adverse reactions ("Cytokine Release Syndrome") experienced by the six volunteers who had received the investigational drug did not involve errors in the manufacture of TGN1412 or in its formulation, dilution or administration to trial participants. The MHRA therefore concluded that an "unpredicted biological action of the drug in humans" is the most likely cause of the adverse reactions in the trial participants. The clinical trial was a single center, double-blind, randomized, placebo-controlled, single escalating dose study of TGN1412 administered intravenously to healthy volunteers. The dosage of TGN1412 administered to the volunteers in the trial was 500 times less than that given to monkeys in preclinical testing, at least some of which had developed swollen lymph nodes.