Officials say six volunteers have fallen ill after participating in a clinical trial in the French city of Rennes and one of them is brain-dead.
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The chief neuroscientist at Rennes Hospital, Professor Gilles Edan, said in addition to the brain dead volunteer, three others could have “irreversible” brain damage.
All six men in hospital were aged between 28 and 49 and were healthy when the trial began on 7 January, she said.
The six patients were in good health until taking the oral medication in Rennes, north-west France, French Health Minister Marisol Touraine said in a statement.
“Toxicity deaths in Phase 1 trials are rare”, said Daniel P. Carpenter, a professor of government at Harvard and an authority on the U.S. Food and Drug Administration.
A total of 128 volunteers took part in the drug test. The subjects were between the ages of 18 to 55 and were considered healthy.
The drug was produced by the Portuguese pharmaceutical company Bial, which said Friday that 108 healthy people had already taken part in the trials and had no moderate or serious reactions to the drug, a new molecule to treat pain.
The study was a Phase I clinical trial, in which a drug is tested on humans for the first time, after likely tests on animals and in the laboratory to ensure its safety.
“I was deeply moved by their suffering”, Touraine said after visiting the patients and their families.
It’s rare for volunteers to fall seriously ill during Phase 1 trials, which study safe usage, side effects and other measures on healthy volunteers, rather than drug effectiveness. This was the first time the drug was tested in humans after being tested in animals.
In a statement, the Portuguese firm insisted it had followed “international best practice” in developing the drug and said it would cooperate with the investigation to “determine in a rigorous and exhaustive manner” what had happened. It was not immediately clear whether the six were among a larger group of volunteers involved in the tests or what dose they had been given.
Bial halted the trial a day later, she added.
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Biotrial – which has its headquarters in Rennes and offices in London and Newark, New Jersey – said it has more than 25 years of experience in clinical trials and uses “state-of-the-art facilities”. The trial has been stopped and all volunteers have been recalled. One other person doesn’t have symptoms but remains under medical surveillance.
