Three investigations were launched to understand how the BIA 10-2474 molecule was able to lead 6 people to the hospital. One is brain dead and 4 others are in serious condition.
Adverse effects of “exceptionally serious”. 6 participants in a clinical trial were hospitalized at the Rennes University Hospital (Ille-et-Vilaine) while they were testing a developing molecule. One of them is brain dead. For the others, the doctors observed “deep lesions in the brain, of the necrotic and hemorrhagic type,” said the head of the neurology department of the CHU, Gilles Edan at a press conference.
90 people involved
A total of 128 volunteers were included in this clinical trial, organized by the private research center Biotrial. 90 of them received the test molecule. All were called back in order to carry out analyzes. A dedicated number has also been made available to them: 02 99 28 24 47.
The hospitalized victims are the participants who ingested the highest doses of the molecule, developed by the Portuguese laboratory Bial, and repeatedly. “The first symptoms appeared on January 10 in a person,” said Marisol Touraine. The other five were gradually hospitalized. “
An approved test
The volunteers joined a phase I clinical trial, which evaluates the safety of a molecule. The private Biotrial center which organized it received approval from the Ministry of Health. The molecule had received all the necessary authorizations in June and July 2015. It has previously been tested on several animal species, including the chimpanzee, which has characteristics very similar to humans.
The research “was carried out in compliance with the rules of international good practice, with the performance of tests and preclinical trials, particularly in the toxicology area,” Bial said. in a press release. The results, obtained in accordance with international guidelines, allowed the launch of clinical trials in humans. “
Analgesic molecule
The molecule tested, probably named BIA 10-2474, acts on the endocannabinoid system, which regulates mood, appetite and muscle relaxation. According to the Bial laboratory, it is an inhibitor of an enzyme responsible for breaking down an amino acid, phenylalanine. In the brain, it is transformed into another amino acid necessary for the production of proteins and neurotransmitters.
A form of phenylalanine has in particular been implicated in chronic pain, motor disorders associated with Parkinson’s disease and depression. However, the objective of the laboratory was to find a drug “with potentially analgesic properties”, according to the ANSM. Corn the Bial site indexes its molecule as indicated in neurological and psychiatric pathologies.
Three investigations were carried out in order to determine the responsibilities. The judicial police, the General Inspectorate of Social Affairs (Igas) and the National Medicines Safety Agency (ANSM)
Six victims in serious condition in Rennes after a therapeutic trial: The keys to understanding
Posted by Why actor on Saturday, January 16, 2016
Clinical trial in Rennes: 3 investigations underway to understand accidents linked to the BIA 10-2474 molecule https://t.co/p51loIt7dC #health
– Pourquoidocteur (@Pourquoidocteur) January 17, 2016
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