Friday, January 15, 2016

Research subject brain-dead after Biotrial clinical trial disaster in France, five others hospitalized

The latest clinical trial tragedy in Rennes is sounding very similar to the TGN1412 disaster at Northwick Park in 2006, which sent six previously health subjects to the ICU with multi-system organ failure.  No word yet what drug was involved, or who the sponsor was, but it was conducted at a Biotrial clinical trial unit in Rennes.  Biotrial has a brief message on its web page that indicates that this was a "first-in-man" trial, like the TGN1412 study.  

Biotrial has also has trial sites in Newark and Montreal in addition to its European sites.

UPDATE: Reuters is reporting that the manufacturer of the drug in question is BIAL.

UPDATE 2: The Independent mentions the Dan Markingson scandal in this review of troubled drug trials.

UPDATE 3. Science has a good summary of what is known so far about the trial, noting that the drug in question is probably a compound called BIA 10-2474, which was being developed for "neurological and psychiatric" pathology.

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