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J Young Pharm. 2010 Jul;2(3):332-6. doi: 10.4103/0975-1483.66810.

TGN1412: From Discovery to Disaster.

Author information

  • Department of Pharmaceutical Sciences, School of Pharmacy, Northeastern University, Boston, MA, USA.

Abstract

After a drug is confirmed as safe and efficacious in preclinical studies, it is tested in healthy human volunteers for first in man trials. In 2006, a phase I clinical study was conducted for a CD28 superagonist antibody TGN1412 in six human volunteers. After very first infusion of a dose 500 times smaller than that found safe in animal studies, all six human volunteers faced life-threatening conditions involving multiorgan failure for which they were moved to intensive care unit. After this particular incident, a lot was changed over how first in man trials are approved by regulatory authorities and the way clinical trials are conducted. This review primarily deals with preclinical studies conducted by TeGenero, results of which encouraged them to test the antibody on human subjects, reasons why this drug failed in human trial and aftermath of this drug trial. In addition, another drug-Fialuridine which failed in phase 2 clinical trial leading to death of five human subjects is briefly reviewed.

KEYWORDS:

Clinical trials; Fialuridine; TGN1412

PMID:
21042496
[PubMed]
PMCID:
PMC2964774
Free PMC Article
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