The initial test of a new drug has gone horribly wrong in London sending all six paid volunteer men into intensive care with multiple organ failure. Monoclonal Antibodies stimulate the immune system and are increasingly used in Cancer Therapy and have promise to treat other auto-immune diseases. The drug from German biotech company TeGenero having passed animal testing was given to establish the human dose and response data.
Catastrophic Immune Response A catastrophic over-stimulation of the immune system may have caused the horrific reactions suffered by six men taking part in the first human clinical trial of an experimental drug. An investigation by New Scientist suggests the drug may have caused a super-immune response – sending white blood cells called T cells rampaging through the body destroying its own tissues.In other words, part of the human immune system is turned on when two independent switches are simultaneously flipped activivating a T cell to attack a specific target. The two key system, one from the target and one from the antibody, keeps the immune system specific to the target. The experimental drug TGN1412 was designed with the ability to flip both of the activation switches on a specific sub-set of regulator T cells that diminish the immune response. It didn’t work and the company has released a Statement re: TGN1412.
TGN1412 is a monoclonal antibody but works slightly differently from other similar drugs. It is a “superagonist”, causing a far greater immune cell response. It also does not require a second, specific trigger to kick-start this response, as do other monoclonal antibodies affecting the same T cell receptor.
As with all medical tragedies, there are groups that are quick to point blame regardless of the fact that The Risks of Clinical Trials are always present.
Russian Roulette Do you see the man to the right? The one who looks like the evilest German scientist to ever stumble in blood-smeared scrubs out of a Nazi laboratory? Gaze carefully upon the ominous shadowing falling upon his cadaverous features, the inhuman leer. Yes, readers, you are looking upon the horrible visage of none other than Dr. Thomas Hanke, Chief Scientific Officer of TeGenero, whose drug TGN1412 had six men in trials tearing at their skin and screaming.What this horrific incident shows is the extreme difficulty for human understanding to safely design ways to alter the complex physiology of human health and disease. I strongly suspect that the anti-business left have members that are the most vocal in insisting that someone find a cure for AIDS right now! Drug company bashing has become political sport but this tragedy should remind everyone that effective therapies, much less cures, are expensive to find and develop. Any winners that emerge must also cover the costs of the failures.
