Rennes trial the questioning of confirmed molecule

The expert committee to find the scientific cause of the accident that occurred in January at Rennes clinical trial in volunteers, confirmed that the molecule of the Portuguese Bial laboratory was involved either by direct action or indirectly. Based on the expertise and additional information provided by Bial in particular, “the committee confirmed that the mechanism behind the Rennes accident exceeded the only inhibition of FAAH,” in other words, the molecule acted not only on the FAAH enzyme that was targeted, but probably also on other brain enzymes that were not, says the national Agency of drug health (ANSM).

This is ANSM who had set up this temporary specialized scientific committee (CSST) on inhibitors of FAAH (Fatty Acid Amide Hydrolase) after the dramatic accident at Rennes last January as part of a clinical trial with healthy volunteers. Six volunteers participating in the clinical trial phase 1 of this substance had been hospitalized in January and one of them had died. Four survivors had brain damage and another no. The accident “implies very likely the molecule itself, either by direct action or by means of a metabolite”, that is to say a product of the degradation of drug absorbed, will add -she.

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The test molecule “BIA 10-2474” laboratory was mostly referred pain. These findings were published a week after a “second and final meeting” of the committee. “Studies in animals (prior to human trials) were again examined in detail, including on the basis of additional evidence, but does provide no new information, particularly in terms of a mechanism of toxicity, “she said. The Agency states that “a complete report, which notably detail the preferred hypotheses to explain the toxicity of the molecule laboratory Bial, conclusions and recommendations of the committee, will be available soon.”

In their first report, the experts had speculated a dose accumulation effect administered in hospitalized volunteers, noting that the passage of a daily dose of 20 mg administered to a previous group to the 50 given to victims was “problematic”. Besides the molecule, they found a medical history of some volunteers (head injury for the deceased volunteer, hypertension in another hospital) which should have led to the spread of this clinical trial.


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