A person is brain dead and five others were hospitalized after a phase I clinical trial in France went horribly wrong turned. At least three of the patients may suffer from irreversible brain damage if they survive, a doctor treating said today.
The patients were previously healthy volunteers who participated in a study by Biotrial, a private company in the city of Rennes, to test the tolerance of a drug candidate. French officials have not announced any drug, and it is still not clear why many others who participated in the study since it began in July has apparently not experienced similar serious side effects.
details of the accident have been slow to emerge. Biotrial, a research organization known contract established in 1989, has notice of a paragraph on its website today said, without providing details, that in a first study in men, the events "serious adverse in relation to test drug occurred in some subjects." (A few hours later, the company issued another statement saying: "Our thoughts are with the volunteers and their families, we work hand in hand with the health authorities to understand the cause of this. accident. ")
at a press conference in Rennes this afternoon, the French health Minister Marisol Touraine said Biotrial testing a compound acting on the system endocannibanoid body, a group receptor proteins that meets the naturally made compounds in the body as well as components of cannabis. The drug temporarily for multiple disorders, including neurodegenerative diseases and anxiety, was developed by the Portuguese pharmaceutical company Bial. Contacted by Science today, a spokesman Bial said she could not comment, but the company will issue a press release about it later today.
Speculation on the Internet focuses on a compound named BIA 10-2474, which, according to the website of Bial, is a candidate drug for the "neurological and psychiatric pathologies," which is currently in Phase I test.
Speaking of the news France info radio stations today, neurologist Gilles Edan of Rennes University hospital Centre said the first patient in the study arrived Sunday with symptoms very severe than the team initially thought Edan could be caused by a stroke. the patient soon deteriorated further and is now brain dead, Edan said. Four other patients have neurological symptoms of varying severity, he added, but not in a coma. "of these four, three already have a pretty table severe clinical danger that even in the best situation, there will be an irreversible disability," said Edan. Because the effects of drugs on humans are not known, patients should be closely monitored, he said. "We can not make a definitive prognosis." The sixth patient has no symptoms, but is under surveillance.
Touraine, who visited the hospital today, said the six are men aged between 28 and 49 years. She said the drug had been tested on animals, including chimpanzees, and the National Agency of France for medicine and safety of health products (ANSM) approved the trial on June 26, 2015. The plan was to enroll 128 volunteers aged between 18 and 55; the trial should first test a single dose and multiple doses, and finally the combination of medication with a meal. So far, 0 people received doses ranging drug while others received a placebo, Touraine said. (Phase I studies are generally not a placebo ;. We do not know why it did)
The six volunteers who were hospitalized all received multiple daily doses, the first that was given on January 7. The first symptoms on 10 January, Touraine said, and the trial was halted the next day
Touraine did not speculate on why the symptoms only appeared in this group and not in the previous voluntary . it is possible that the six were the first to receive multiple doses of the drug, or drug lot was contaminated in some way. (All six were "in the same test group," said Edan.) Each volunteer who took the drug for the trial will be contacted, Touraine says, presumably to be checked for any adverse events have gone unnoticed.
Touraine said that prosecutors are investigating Rennes and ANSM will investigate as well. Meet with victims and their families now was "an intense moment of emotion," said Touraine. "The shock is even greater because the people involved [in phase I trials] are healthy, not sick, and they obviously do not expect to face such accidents."
Phase I studies are designed to test the safety and tolerability of a drug, and how and how fast the chemical is processed by the human body. Most of these studies are performed by specialized companies of research contracts; the subjects are generally healthy volunteers who receive a modest compensation.
Serious incidents in Phase I studies are rare, but they can never be completely excluded because the behavior of a drug in animals are not always a good predictor of its effects in the man. The last similar incident known to the public occurred in 06 when six men in the UK suffered a severe organ dysfunction after receiving small doses of a monoclonal antibody called TGN1412.
With reporting by Tania Rabesandratana .
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