France’s ANSM Investigating Trial Halted After Five Patients Hospitalized, One Brain-Dead

Regulatory NewsRegulatory News | 15 January 2016 |  By 

France’s National Agency for Medicines and Health Products Safety (ANSM) is currently investigating a Phase I clinical trial that’s been halted after the investigational drug caused brain damage in one healthy volunteer and hospitalized five others.

The trial, conducted in the northwestern city of Rennes, France, was run by the contract research organization Biotrial with a total of 90 volunteers for the sponsor Bial, a Portuguese company. The investigational drug involved is BIA 10-2474. France's Health Minister Marisol Touraine said the drug was a fatty acid amide hydrolase (FAAH) inhibitor meant to act on the body’s endocannabinoid system, according to the Guardian.

“During a FIM [first in man] study which was being conducted for a sponsor, serious adverse events related to the test drug have occurred in some subjects at our CPU [clinical pharmacology unit],” Biotrial said in a statement on its website. “The trial has been conducted in full compliance with the international regulations and Biotrial’s procedures were followed at every stage throughout the trial, in particular the emergency procedures for the transfer of subjects to the hospital. We are in close and regular contact with the Health Authorities and Ministry in France. The priority at Biotrial remains the safety of our subjects.”

ANSM said in an announcement on Friday that it will inspect the clinical trial site. Touraine is also travelling to Rennes to the hospital where the patients are being treated. An European Medicines Agency spokeswoman told Focus that ANSM is conducting the investigation.

UK drug regulators said in a statement that there are no clinical trials in England using the Bial compound.

French prosecutors on Friday also opened an investigation into how the volunteers suffered serious injuries, a spokesman for the Paris prosecutor’s office told the Wall Street Journal.

Issues with early-stage clinical trials going badly wrong are rare, according to Reuters, which noted a previous trial disaster in London in 2006, when six healthy volunteers given an experimental drug ended up in intensive care. 

France’s Ministry of Health Statement

Biotrial Statement



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