- 2006, 8 men signed up for a 3-day clinical drug trial in Britain. They were offered 2000 pounds for participating.
- The drug was successful on trails on monkeys, however, when experimenting on humans the results were horrendous.
- It was TGN1412. The drug was for leukemia treatment.A type of antibody. It was supposed to educate the immune system to deal with cancer.
- 2 placeboes and 6 with the drug (1/500 of the monkey's dose). Reaction to the drug began in less than for a patient
- The bodies responded in shock
- the first side effects experienced include: strong headaches, migraines, increase in temperature, severe lower back pain, aggressive shivering, feeling of lower temperature, vomiting, loss of control in bowels
- After 4 hours trail doctor ended up going ICU of the hospital nearby. The NCS doctors advise the parexel trail team to administer fluids, anti-histamine, and treatment dose of hydrocortisone.
- By the 11th hour someone was sent to ICU with very low blood pressure and lung affected by the drug.
- The six men had multiple organ failures.
- First suspicions were that they suffered from an infection from a contaminated dose of tgn1412.
- Patients were treated as cytokine release syndrome. With 1000mg steroids.
- Severe swelling from being pumped with fluids
- after 48 since that start of the trail 4/6 of the patients saw improvement.
- A patient called Ryan was in the hospital for 4 months. He suffered from pneumonia, septicemia and dry gangrene.His fingertips fall off ad he had part of his foot and toes amputated.
- 23 days after the trial began the government body that had licensed the trail publishes the initial report. The trial was conducted as intended.
- The report concludes that the adverse effects were the result of "an unpredictable biological action of the drug in humans"
- 2009 parexel settles out of court. All six men receive undisclosed amounts.
- An independent report into the tgn1412 trial made 22 recommendations to improve the safety of first in man trials.
- It is now recommended that high-risk trials take place within a hospital with access to intensive care
- The report was adopted by the European medical body and applied to the whole of europe
- In 2013 TGN1412 successfully phase one in human trails in Russia under the new name TAB08. They used 0.1% of the antibody used in the London trial and it was infused into the body 40 times more slowly.
- This type of monoclonal antibody could be still used an effective form of treatment for autoimmune disease in the future.
jan 30 2018 ∞
feb 5 2018 +
feb 5 2018 +