In the press release, translated from French, Marisol Touraine, Minister of Social Affairs, Health and Women’s Rights, expressed the seriousness of the event, adding that no such comparable event has ever been documented. The six men who were hospitalized were the group that received the highest dose. French health authorities have said three of the hospitalised volunteers face possible brain damage.
Advertisement
He stressed that contrary to preliminary news reports the drug was not based on cannabis but interacts with the endocannabinoid system.
The company, which has been carrying out drug trials on behalf of pharmaceutical companies since 1989, said the situation is “even more upsetting given that there is as yet no explanation”.
The Rennes University Hospital announced the death in a statement on Monday (AEDT), but did not identify the patient, who had already been brain dead.
The trial, which began on January 7, involved 90 healthy volunteers who were given the experimental drug in varying doses at different times. Biotrial, a private laboratory, had been testing it in Rennes, in northwestern France.
The Paris prosecutor’s office said the investigation was expanded after the death to include potential manslaughter charges.
The Biotrial laboratory in Rennes, western France, where a clinical trial of an oral medication left one person dead and hospitalised another five.
Exposure to the drug in the first-in-man (FIM) trial – conducted by clinical research organisation Biotrial on a compound in development at Portuguese pharma company Bial-Portela – seems to have caused serious neurological adverse reactions.
Ten of the other 84 have been tested, but did not display any of the “anomalies” of those admitted, the Rennes hospital said in its statement.
The orally-active drug – BIA 10-2474 – was meant to treat mood and motor disorders associated with neurodegenerative disorders and anxiety and is a fatty acid amide hydrolase (FAAH) inhibitor.
New EU regulations to speed up clinical drug trials and streamline testing procedures across the 28-nation bloc are due to take effect in May.
Advertisement
Biotral said in a statement on Sunday that it planned to work with the global scientific community to develop “changes to the standards governing such trials”, without giving further details.
