Biotrial, the CRO that ran a Phase I study that proved deadly, said it's working with authorities to piece together what went wrong while trying to move its business forward.
Last week, a routine safety trial of a drug from Bial turned tragic when 6 previously healthy volunteers were hospitalized with severe neurological side effects and one later died. Biotrial and Bial halted dosing as French regulators descended on the Rennes study site, and each company has spent the past week complying with a government investigation into how a drug that looked safe in preclinical testing went awry in human trials.
The study was "conducted in full compliance with the international regulations," Biotrial said in a statement last week, "and Biotrial's procedures were followed at every stage throughout the trial, in particular the emergency procedures for the transfer of volunteers to the hospital." For its part, Bial called the trial a "tragic and unfortunate situation," saying the company's "thoughts and solidarity go out to the family" of the volunteer who died.
Both companies said they obeyed international guidelines in preparing the trial, completing the requisite animal tests and toxicology screens before enrolling patients. French regulators approved Bial's plans for a Phase I trial based on those results, the companies said, and Biotrial said it followed the law throughout.
"Our thoughts go out to the volunteers and their families," Biotrial said in a statement on its website this week. "We are working hand in hand with the health authorities to understand the cause of this accident."
The CRO's management has not spoken publicly about the incident, commenting only through prepared remarks.
Meanwhile, French authorities are moving forward with their investigation of the trial, which administered the drug in question to 90 healthy volunteers in total. The 6 hospitalized patients came near the end of the dose-escalating study, receiving multiple daily administrations of the drug, the company said. French health minister Marisol Touraine said in a news conference on Friday that investigators had yet to determine whether the problems were related to the drug's mechanism of action or the result of contaminated doses, but investigators are calling back all of the trial participants to screen them for signs of neurological impairment.
- read the statement