Did anyone die in the TGN1412 trial?
A drug trial gone terrifyingly wrong. In 2006, the clinical trial of a monoclonal antibody drug called TGN1412 nearly killed 6 healthy volunteers.
What went wrong with TGN1412 trial?
It found that preclinical studies performed with TGN1412 failed to consider what constituted a safe dose for use in humans. In addition, it made 22 recommendations for improving the safety for Phase I trials of higher risk medicines.
What happened to the Elephant Man drug trial?
German drug manufacturer TeGenero went bust after the disastrous first human trial of its supposed wonder cure TGN1412. It emerged the firm had inadequate insurance, for a total of only £2million – leaving the victims in limbo as the company that conducted the trial, Parexel, at first refused to accept joint liability.
How much did Parexel payout?
Then in summer last year Ryan is thought to have collected £2million in a settlement with Parexel, the US-based firm that ran the trial. Since then some family members have become concerned that Ryan, of Highbury, North London, is spending the money so fast he won’t have enough to support himself in the future.
Was TGN1412 tested on animals?
According to TeGenero, the drug has been tested extensively in laboratory animals including rabbits, dogs and monkeys with no drug-related adverse events. However, several studies have pointed out crucial species differences between humans and monkeys in the particular function of the immune system.
How was TGN1412 administered?
The mAb was administered by IV infusion (duration of 3 to 6 minutes) to six healthy subjects at a starting dose of 0.1 mg/kg. This dose was reported to be 1/500th of the safe animal dose.
Where was TGN1412 made?
the University of Würzburg
Theralizumab (also known as TGN1412, CD28-SuperMAB, and TAB08) is an immunomodulatory drug developed by Thomas Hünig of the University of Würzburg.
What was the elephant man’s condition?
Background: In 1986, two Canadian geneticists had demonstrated that Joseph Merrick, better known as the Elephant Man, suffered from the Proteus syndrome and not from neurofibromatosis type 1 (NF1), as was alleged by dermatologist Parkes in 1909.
What is a mAb drug?
Monoclonal antibodies (MABs) are a type of targeted drug therapy. These drugs recognise and find specific proteins on cancer cells. There are many different MABs to treat cancer. They work in different ways to kill the cancer cell or stop it from growing.