Original TGN1412 drug trial left volunteers with multiple organ failure
The lawyer for a number of victims of a clinical trial which seriously injured several people in 2006 has welcomed reports that a phase II trial of the drug, which has been the focus of far greater development and understanding, is about to begin in Russia.
The drug, known as TGN1412, caused a cytokine storm, an extreme autoimmune reaction leading to multiple organ failure, in six paid volunteers in 2006.
All the men required intensive care treatment at Northwick Park Hospital, London, shortly after being given a starting dose of the drug , in quick session, by a contract research organisation.
Gene Matthews from Leigh Day represented the majority of the seriously injured men in a legal battle for compensation.
The drug’s developer, TeGenero went bankrupt.
In 2006 a Russian investor acquired the commercial rights to TGN1412.
The drug was renamed TAB08 and was developed further by the Russian biotechnology company TheraMAB who are about to begin new trials into the drug to evaluate it as a potential treatment for rheumatoid arthritis.
An editorial in the British Journal of Clinical Pharmacology has said that the drug is set for a “potentially triumphant return,” editor, Adam Cohen explained, “TGN1412 was a chilling example,” of how “a sophisticated product could be destroyed by inadequate development.”
According to the British Medical Journal phase II trials will begin this June in Russia.
TheraMAB’s chief executive, Dmitry Tyrsin, told Reuters the company is seeking approval to extend the trial to the United States later this year. Trials in patients with lupus and psoriasis are also planned.
“It is deeply regrettable that it took the life-threatening injuries to our clients to highlight that the dose of the drug needs to be properly considered by appropriately qualified experts, this is something that could have been readily done before our clients were injured.
“The safe conduct of clinical trials, based on sound research and appropriate expert input, is of importance to us all. It is perfectly possible that this drug may have significant beneficial health implications.
“These most recent developments with the infamous TGN1412 drug should be widely welcomed.”