Renuka Munshi, Urmila Thatte | Perspectives in Clinical Research | v.4(1) | Jan-Mar 2013 | Source: NCBI-PMC
In March 2006, eight healthy volunteers in a phase I trial received a T cell agonist at Parexel’s clinical pharmacology research unit at Northwick Park Hospital, London.[1] This was the first human trial of TeGenero’s TGN1412, a new humanised monoclonal superagonist of the CD28 T cell surface receptor,[2] designed to mitigate autoimmune and immunodeficiency disease. The six men who received the active component rapidly developed catastrophic multisystem failure; the remaining two, who received a placebo, were unharmed. The participants who had developed serious complications received very little compensation for their injuries because Parexel, the CRO that conducted the trial for TeGenero, maintained that it had carried out all procedures correctly and hence was not responsible for the unforeseen reactions caused by the drug and the insurance cover (£ 2 million) that TeGenero (the sponsor) had, was not enough to cover the long-term health consequences of this disaster, as the volunteers are at risk of developing life-threatening conditions such as autoimmune diseases or cancer later in life.[3,4]