Update

What we know: Biotrial clinical trial tragedy

By Melissa Fassbender contact

- Last updated on GMT

Related tags: Clinical trial

What we know: Biotrial clinical trial tragedy
On Friday, the French Minister of Health addressed the public pledging to provide answers after one man was declared clinically dead as the result of a clinical trial gone wrong.

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.

As Outsourcing-Pharma.com previously reported​, six people have been hospitalized and one declared clinically dead.

Pierre-Gilles Edan, neurology department head at the Rennes hospital, has since explained that three of the men are suffering a "handicap that could be irreversible.​" Another is suffering "neurological problems​" and the sixth is being monitored, but showing no symptoms.

Of the six hospitalized, the ages range from 28 to 49. All are male.

What we know now

Records show that Biotrial filed for the Phase I clinical trial of a the new molecule, developed by BIAL laboratory, on April 30, 2015.

The molecule was being developed to treat mood disorders and anxiety and movement disorders related to neurodegenerative diseases, and contrary to previous reports, the drug contains no cannabis, and is not a derivative of cannabis.

The National Agency of Drug Safety (MSNA) authorized the trial on June 26, 2015, it began soon thereafter on July 9, 2015 at Biotrial. Previous to the Phase I trial the drug had been tested in animals, including chimpanzees.

The trial was made up of 128 healthy male and female volunteers ranging in age from 18 to 55 years. Ninety were given the drug, while others received a placebo. 

The first volunteers began taking the drug Thursday, January 7th, with the first symptoms appearing in a volunteer three days later on January 10th. Symptoms appeared in the five other volunteers in the following days.

According to the press release, the hospitalized volunteers had received the medication in higher doses.

Bial explained in a release that 108 patients had been given the drug previously throughout the trial without any "moderate or severe adverse reactions​."

The next steps

Biotrial has halted testing and the MSNA and the General Inspectorate of Social Affairs (IGAS) have launched an inspection into the site in order to verify compliance with regulatory procedures.

Other trial volunteers are being identified and personally contacted in order to receive medical examination at the University Hospital of Rennes.

Touraine has asked for a final report from the IGAS by the end of March.

Bial's statement

In a statement released from Bial​, the company asserts the trial was held “Following the best international medical practices​.”  

According to the release, several BIAL representatives are currently at the site to monitor the situation and are cooperating with proper authorities.

Together with all the relevant authorities, BIAL is strongly committed to ensuring, first of all, the well-being of all participants in this trial and to determine thoroughly and exhaustively the causes which are at the origin of this situation​.”

Related topics: Clinical Development

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