Six men have been admitted to the intensive care unit of a North London hospital after suffering a severe reaction to an antibody administered in a Phase I clinical trial.
The men had volunteered for a study of a compound called TGN1412, in development by German biotechnology company TeGenero as a treatment for chronic inflammatory diseases and leukaemia.
Shortly after being dosed with the drug, the men experienced multi-organ failure and two are said to be critically ill. Two other men who received placebo were unharmed.
The trial was being conducted by contract clinical research organisation (CRO) Parexel, which owns and operates the dedicated clinical research facility unit at the Northwick Park Hospital where the trial took place.
The statement from Parexel about this tragedy can be read here.
Roy Poses at Health Care Renewal has written a number of times recently about US contract research houses.
His concerns have been to do with quality standards.
Insider is in no way implying that this was an issue in this case. But it will be interesting to see what the, now inevitable, enquiry turns up.
Some questions Insider would raise would include: the rationale for dose selection; the Ethics Committes' review of the protocol; experiences with similar compounds and finally the animal toxicity data.
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