Home: Rheumatoid arthritis :: tgn1412 ra, rheumatoid arthritis, complications, tegenero

TGN1412 RA -- When Good Intentions Go Wrong

At the outset, it seemed like a very good thing: the development of TGN1412 for the treatment of autoimmune diseases like rheumatoid arthritis (RA) and certain cancers, like leukemia. With TGN1412, RA sufferers would have a greater reason to hope for a chance to say good-bye to their painful and debilitating disease. The drug, an immunomodulatory formulation, was designed to act on factors that cause a body's immune system to malfunction.

By taking TGN1412, RA patients' immune systems would be boosted by promoting cell response. It is designated as a superagonist, something that stimulates the T cells on its own, without the need for another, specific agent to perform the action it's supposed to do; hence, it's also a monoclonal antibody. And since rheumatoid arthritis is an autoimmune disease, meaning the immune system backfires and starts attacking healthy tissue instead of pathogens, TGN1412 would seem to be a godsend.

TGN1412 is developed by German company TeGenero Immuno Therapeutics and manufactured by Boehringer-Ingelheim. In lab experiments with animals, no adverse reactions were seen and everything went well as expected. However, the human trials were a different thing. Six men who were paid to participate in the trial (as human guinea pigs) suffered extreme complications and side effects from the drug. The trials were conducted in London, England, and the trial subjects were hospitalized there soon after the tragedy befell them. All men were placed in intensive care, with two of them in critical condition. According to news reports, the men also suffered from multiple organ failure.

Other manifestations of the complications showed themselves in horrific ways, says friends and relatives of the patients. They describe one patient whose head swelled to abnormally large proportions and whose limbs suffered discoloration. Another patient suffered certain overgrowths, prompting comparisons with Joseph Merrick, the so-called Elephant Man. Other scientists believe that instead of suppressing the immune system as it was supposed to do, TGN1412 actually caused a super reaction, activating it even more.

According to a statement by chief scientific officer Dr. Thomas Hanke on TeGenero's Web site, every precaution and every regulation was followed relating to the testing of the drug, and that the company is doing its utmost to cooperate with the authorities to facilitate the investigation into what went wrong. And even though there are no plans yet to pursue testing of the drug as of March 2006, let's hope that TeGenero or other companies come up with successful and save ways to treat RA. It's just too bad: with TGN1412, RA patients and individuals with other diseases could have been one step to closer to greater pain relief and perhaps even a cure.