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May 23, 2016   |   News

Phase I Clinical Trial – Rennes

News Release

May, 23rd 2016

BIAL became aware of the final report of the Inspection Générale des Affaires Sociales (IGAS), on the incident in a Phase 1 clinical trial performed by Biotrial, with BIA 10-2474 molecule last January 2016.

This report does not enable to determine the causes of the accident, nor on the death of one of the volunteers who participated in the clinical trial.

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April, 20th 2016

BIAL became aware of the final report of the Temporary Specialist Scientific Committee established by the French National Agency for Medicines and Health Products Safety (ANSM – Agence Nationale de Securité du Medicament et des Produits de Santé) on the events in Rennes which occurred during a phase I clinical trial performed by BIOTRIAL, with the experimental molecule BIA 10-2474.

The CSST has not identified the definitive causes and circumstances of the accident or volunteer’s death. Further investigations are being conducted by IGAS (Inspection Générale des Affaires Sociales), as well as by the French prosecutors.

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February 4th 2016

BIAL became aware of the disclosure of the preliminary findings of the Inspection Générale des Affaires Sociales (IGAS) report, related to the incident in a Phase 1 clinical trial with BIA 10-2474 molecule.

The IGAS report concludes that the causes of the adverse reactions observed in the trial could not be determined, and that the Clinical Trial Protocol is in accordance with the inherent legislation as well as with the existing recommendations, as previously approved by the French Regulatory Authority (ANSM - Agence Nationale de Securité du Medicament et des Produits de Santé).

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January 19th 2016

Following the serious incident occurred with one of BIAL’s experimental molecules at the Phase I stage with healthy volunteers in France, BIAL deeply regrets the death of one of the volunteers participating in the trial.

We are continually and closely following the health state conditions of the other 5 volunteers who had been hospitalized and we are encouraged by the most recent news. The volunteer who had no symptoms has already returned home, two other volunteers were transferred to local hospitals within their residence areas, and two volunteers still remain at the University Hospital of Rennes. We have been informed that the most recent medical examinations present a positive scenario. We will continue to accompany the volunteers’ condition, and expect a full recovery.

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January 17th 2016

The University Hospital of Rennes has just declared the death of the volunteer who was in a state of brain death, after participating in a Phase 1 clinical trial with an experimental molecule of BIAL, that was being held in a clinical trial unit in France.

Our thoughts and solidarity go out to the family of this volunteer.

BIAL will keep following the hospitalized volunteers and working closely with the Health Authorities to understand the causes of this tragic and unfortunate situation.

 

 

 

January 15th 2016

As part of a clinical trial that was being held in a Phase 1 clinical trial unit in France, since June 2015, with an experimental molecule of BIAL, we were informed that five participants showed severe symptoms. Following the best international medical practices, they were immediately transferred by the company responsible for conducting the clinical trial to observation at the University Hospital of Rennes, being currently under permanent medical supervision.

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Other information

Official information of the health state condition of the volunteers:

About Clinical Trials:

 

Media Contacts
BIAL
Susana Vasconcelos
E. susana.vasconcelos@bial.com

For French media:
Brunswick
Tel. +33 (0) 1 53 96 83 83

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