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Portuguese company monitoring clinical trial of experimental drug causing problem in France

Xinhua, January 16, 2016 Adjust font size:

Portuguese pharmaceutical company Bial said on Friday that it is closely monitoring all those participating in a clinical trial of the experimental drug that has caused the hospitalization of six people and one brain dead in France.

In a statement, Bial said that it is "strongly committed to ensuring the welfare of all participants in this trial, as well as determine accurately and comprehensively the causes which are at the origin of this situation."

The company said the development of the new molecule in the area of pain follows from the very beginning all international practices, with the completion of pre-clinical tests and trials, particularly in the area of toxicology.

It said that 108 healthy volunteers had participated in this trial with the new molecule without any moderate or serious adverse reaction.

The company said that the trial was approved by the French authorities and the ethics committee, and is in accordance with legislation that provides the framework for clinical trials. Endit