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Saturday, August 5th 2006

TGN1412

I’m late to the ball here. Even so, as it was all over the news when I was in England in March, I thought I’d provide a summary post.

In case you don’t know what I’m talking about, this is one of the worst modern Phase I trial disasters of all time. Six test subjects injected with an immunomodulatory drug called TGN1412, suffered severe excessive immune reactions reactions, swelled up like “elephant” men from inflammation associated with excessive cytokines, suffered gangrene, and possibly face severe long term consequences.

NRI student Nav Modi, one of the “Elephant Men” who nearly died in March during a botched drugs trial in a London hospital, fears he may have only two more years to live.

“It’s a really bizarre feeling when you discover you might be dead in a couple of years or even in a couple of months,” 24-year-old Modi who has just graduated from university and was looking forward to a career in his family’s electrical business told The Sunday Times.

The botched drug test has been one of Health Care Renewal’s category coverage issues. From their first post to the most recent, it’s a good resource.

The broad idea was for the drug to work as an immunosupressant for B Cell leukemia patients by activating regulatory T Cells. An odd idea to say the least, seeing as the drug worked as a superantigen, activating T Cells independent of the T Cells specificity or of the antigen being presented by an antigen presenting cell. The Telegraph provides a description of what might have gone wrong.

The drug, called TGN1412, is an antibody treatment designed for some forms of leukemia and rheumatoid arthritis. It stimulates the production of T-cells with the aim of improving control of a malfunctioning immune system.

“This is a different sort of antibody and I don’t know of another antibody that is on the market that works in the same way,” Sir Gregory said. “It is a different and very potent process and very difficult to predict in advance how mild or severe the clinical response might be.”

Not all explanations of what went wrong have been so kind as to claim that this effect was impossible to predict or judge. In New Scientist,

An immunologist contacted by New Scientist, but who asked not to be named, says: “You don’¬ít need to be a rocket scientist to work out what will happen if you non-specifically activate every T cell in the body.”

Even so, the company that carried out the testing was found to have followed all procedures, and cleared of wrong doing in both an interim report and final report by the Medical and Helathcare products Regulatory Agency of the UK.

The manufacturer (not the same company as the one who carried out the test), TeGenero, filed for bankruptcy limiting the financial compensation available to the six victims. They did have these kind words.

Meanwhile, the future of drug testing and the future health of the TNG1412 victims remains in the air.

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