British health officials have been scrambling to find out what went wrong in a Phase I safety study of a new anti-inflammatory drug. The six men who received doses of TeGeneo's TGN1412 all wound up in the hospital hours after receiving their first dose, two in critical condition. The drug is intended to suppress the inflammatory response of leukemia, MS and rheumatoid arthritis but instead triggered an inflammatory response that caused multiple organ failure. Health officials want to find out more about the results of earlier animal testing and see if the patients received the proper doses in escalating quantities to safely gauge toxicity. The U.S. CRO Parexel was running the study.
- here's the report [1] from the Independent
Links:
[1] http://news.independent.co.uk/uk/health_medical/article351751.ece