The chief neuroscientist at the hospital in Rennes, Professor Gilles Edan, said yesterday there is no known antidote to the experimental drug that Biotrial was testing.
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Of the six male volunteers who were hospitalized, one man is brain dead, three are suffering a “handicap that could be irreversible” and another has neurological problems.
The prosecutor’s office has opened an investigation into what the French health minister Marisol Touraine called “an accident of exceptional gravity … without precedence” at the Biotrial lab in Rennes.
In a press conference Friday, French Health Minister Marisol Touraine described the tested drug as treating mood disorders, anxiety, and motor disturbances associated with neurodegenerative diseases, such as Parkinson’s. “We haven’t found any such accident for a trial in phase 1 in our records”.
In the trial, run by the private research company Biotrial, the 6 men starting taking the investigational drug January 7, in varying doses.
In a message on its website, the company said that “serious adverse events related to the test drug” had occurred.
The health minister said, “the shock is even greater given the fact that the people taking part in clinical trials are healthy”. Then on January 10 the first patient began showing negative symptoms, Touraine said.
Touraine said she was determined to “shed light on” what happened. Persons who have the specific medical condition, for which the drug is being developed, are introduced to the drug during Phase II to see if it can actually help.
All trials of the drug are now suspended, and volunteers participating in the study have been called back. She urged calm and said no drug now on the market was implicated in the failed trial.
Five others were hospitalized at the University Hospital of Rennes, with their conditions raising serious concerns.
The six volunteers who ended up in hospital are all men, aged between 28 and 49, and were the ones who had been given the highest dose of the drug, she said.
The hospitalizations were reported to the French Health Ministry on Thursday night.
Biotrial, which is accredited by the French government, issued a statement on Friday in which it said all “international regulations” were followed. SA, a closely held Portuguese company, led to six patients being hospitalized in France including one person who was put on life support and diagnosed as brain dead.
Phase 1 drug trials test the safety and side effects of new drugs on healthy volunteers.
The trial of the drug containing an FAAH inhibitor had preliminary tests on chimpanzees in July previous year.
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Every year around the world thousands of people take part in clinical trials but incidents like this are very rare, the BBC’s Hugh Schofield reports from Paris.
