Clinical Trials That Went Horribly Wrong

Theralizumab – AKA The Elephant Man Trial Theralizuman is also as TGN1412, CD28-SuperMAB, and TAB08. Thomas Hunig developed it at the University of Wurzburg in 2006.… Trista - December 15, 2022
Potential wonder cure TGN1412 was not so wondrous. Patients had extreme pain before leading to organ failure. The Guardian

Theralizumab – AKA The Elephant Man Trial

Theralizuman is also as TGN1412, CD28-SuperMAB, and TAB08. Thomas Hunig developed it at the University of Wurzburg in 2006. The purpose of the drug was originally to treat B cell chronic lymphocytic leukemia (B-CLL) and rheumatoid arthritis by binding to receptors on the T-cell. The six human participants were assumed that the worst symptoms they’d experience were likely a headache and nausea, but the trial soon spiraled into one of the most infamous medical trials in British history. Shortly after receiving their doses, all patients began experiencing severe pain and vomiting uncontrollably. One patient lost his fingers and toes, another had to have this foot partially amputated. The trial is “the Elephant Man Trial” because one patient’s head swelled up so much that his girlfriend teased him about looking like an elephant.

Severe swelling occurred as a result. Penn Vet

The Cytokine Storm Symptoms

Doctors now know to call the symptoms men experienced cytokine storm. It is where their temperatures soared, their organs failed, and some of their bodies swelled past recognition. One of the participants, Rob Oldfield, had fluid seeping into his lungs and had to breathe through a mask. Ryan Wilson spent four months in the hospital and battled pneumonia, septicaemia and dry gangrene. His father had warned him the night before the trial: “Don’t do it. Your body is a temple.” The volunteers still suffer from weakened immune systems and other side effects.

Participant Rob Oldfield, 21 at the time, had amputated all of his toes and parts of his fingers. Huffington Post

What Went Wrong with the Elephant Man Trial?

Though knowing what went wrong with the trial is difficult, there are a few theories about why it was so ill-fated. One theory claims that the period of drug injection was to blame. Researchers spent over an hour and a half injecting the drug carefully into the animals. However, injecting the entire dosage into the human participants took a mere six minutes. Another theory suggests that animal testing did not translate to human testing accurately because it was done on a macaque instead of a bonobo, so the animal-to-human DNA match was only 94% instead of 98%.

What’s good for the goose is not always good for the gander. Pharma

Parexel on Animals vs Humans

Oddly, one source said that the first infusion in six patients was five hundred times smaller than that found safe in the animal studies, but the volunteers still suffered life-threatening organ failure. Clearly, a disconnect between animal and human studies happened here, resulting in a hugely unfortunate incident for those involved. Parexel, the drug company that ran the clinic where the trial was carried out, was found to have acted within all proper protocols. However, a final report did indicate that the trial had not adequately considered the safe dosage for humans. The company that developed the drug, TeGenero Immuno Therapeutics went bankrupt later that year.