Last week, six participants aged between 28 and 49 were hospitalised after having taken part in a Phase 1 clinical test for
Portuguese drug company Bial, which was testing a new molecule that acts on the central nervous system, with possible affects as a painkiller and on mood swings.
The five participants still in hospital, four of whom have various neurological illnesses, are all “stable”, the French health minister said.
Three investigations have been started, one of which is judicial, to try and understand the reasons for this incident. The health minister said she was expecting the results of these investigations “by the month’s end”.
According to the available information at the moment, the clinical trial involved108 volunteers, 90 of whom were given the drug and the others were receiving placebos. The six who were hospitalised were the group that was given the highest dosage, according to France Presse.
Lusa has learnt that the substance that was being tested had been studied for eight years and had already passed the laboratory and animal toxicology tests before trials using humans.
Bial’s CEO, António Portela, told Lusa he was “deeply shocked” with the death of a volunteer who was participating in the trial in France and said the company was working “tirelessly” to understand what had happened.
“I want, personally and on behalf of Bial, to express our deepest condolences and feelings to the family of the volunteer who died after participating in the Phase 1 test with our experimental molecule”, António Portela told Lusa, adding that the company directors are all “deeply shocked with this situation”.