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TGN1412 Disaster

1st April 2006

18032006_NorthwickPk1.jpgBy the end of March four of the six men who suffered an extreme reaction to the drug TGN1412 were well enough to return home. A fifth was out of critical care and making a steady recovery, whilst the sixth patient remained in critical care, but was fully conscious.

The healthy volunteers were testing an anti-inflammatory drug at a research unit based at Northwick Park Hospital when they suffered a reaction. Eight volunteers were involved, but two were given a placebo.

The men were being paid to take part in a phase 1 trial of the drug TGN1412, a monoclonal antibody (MAB) which was intended to treat rheumatoid arthritis, leukaemia and multiple sclerosis. The trial had been approved and the drug had already been tested on animals and in a laboratory.

An investigation has begun at the unit, which is run independently by Parexel but is on the Northwick Park Hospital site in North West London.

The Medicines and Healthcare products Regulatory Agency (MHRA) immediately withdrew authorisation for the trial. An international warning has also gone out to prevent it being tested abroad.

Parexel said the clinical research organisation had followed regulatory, medical and clinical research guidelines during the study. When the adverse drug reaction occurred, the Parexel clinical pharmacology medical team responded swiftly to stop the study procedures immediately.

Professor Herman Scholtz, from Parexel, said that such an adverse drug reaction occurs extremely rarely and that this is 'an unfortunate and unusual situation.'

The drug has been developed by TeGenero, a German company founded in June 2000. It was manufactured for them by Boehringer Ingelheim who issued a statement saying that 'an additional review of the manufacturing documentation and the pharmaceutical release procedure has confirmed that the material supplied by Boehringer Ingelheim to TeGenero for preclinical and clinical development complied with all pharmaceutical and legal requirements.'

While debate and investigation continues into the cause of this unfortunate event Professor David Isenberg, a rheumatologist at University College London, is concerned that the current problem could undermine confidence in monoclonal antibodies. He said that he wanted to emphasise that 'there have been wonderful successes in the fields of cancer, and the fields of inflammatory diseases, particularly arthritis.' We should not forget that the pharmaceutical arch villain, thalidomide, is now a life-prolonging, sometimes life-saving, anti-cancer drug, said the Times.

Others are concerned about the effect on those volunteering for drug trials and therefore on the future development of life-saving drugs; Professor Janet Darbyshire, who is director of the clinical trials unit of the Medical Research Council, told the BBC, "Without such trials, we're not going to have any new developments for treatment or vaccines."

However, since the events at Northwick Park medical groups have been inundated with people wanting to sign up for trials reported the Guardian.





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