MHRA issues report on TeGenero trial

The U.K.'s MHRA concluded that the adverse events seen in a Phase I trial of TGN1412 from TeGenero (Wuerzburg, Germany) were most likely caused by an unpredicted biological action of the humanized MAb that agonizes CD28. In an interim report, the agency said it found no evidence of contamination or manufacturing problems and that the trial was run according to protocol. The trial was stopped last month after all six healthy volunteers given the MAb had to be hospitalized because of severe inflammatory reactions. TGN1412, which has Orphan Drug designation from EMEA to treat B cell chronic lymphocytic leukemia (B-CLL), is the company's lead compound.

As a result of the unexpected adverse events, the MHRA will convene a group of independent experts to consider what may be necessary in the transition from animal to human studies for biological compounds with novel mechanisms, new agents with a highly species-specific action and new compounds against immune system targets. An interim report is expected within three months. ...