Portuguese pharmaceutical company Bial has heard that an expert panel tasked with investigating the cause of a clinical trial death in France three months ago has found that the volunteer died “as a result of the drug’s toxicity”.
In a report published earlier this week by the French agency for the Safety of Health Products, experts said the incident “seemed clearly linked” to the “molecule” being tested , rather than possible mistakes in how the drug was administered, or its dosage.
“The most likely hypothesis is that the molecule is itself toxic”, the report went on.
Why this was not discovered in earlier trials of molecule BIA 10-2474 on animals is “inexplicable”, its authors added, stressing that “nothing in the data reviewed by the expert panel seemed to point to any reason not to move on to human trials”.
The collapse of the drugs trial undertaken in Rennes earlier this year was covered by national and international media while France’s health minister Marisol Touraine called the incident “the worst of its kind in French medical history”.
Aside from the previously healthy volunteer who died, four others suffered what were described at the time as “life-changing disabilities”.
Bial was the company that developed the molecule, with research company Biotrial in charge of the trial.
Before the panel of experts convened, Portugal’s head of INFARMED (the State authority regulating medicines) said it was far too early to jump to conclusions.
Henrique Luz Rodrigues told Correio da Manhã he was “concerned” that a Portuguese company was involved but that it could not be certain that Bial’s molecule was the reason for things going so horribly wrong.
“There is an association with the molecule but that doesn’t mean that the molecule is the cause”, he said.
But as Wall Street Journal explains this week, the panel has “stopped short of pointing fingers”.
No comments have been made so far by Bial or Biotrial, and WSJ made no mention of the story carried in Portugal in February that testing of the molecule saw three dogs die before it went on for Phase 1 testing on humans (click here).
Article by kind permission of http://portugalresident.com
