The French ministry statement said those who had fallen ill had taken an oral medication in the first phase of testing, which was studying safe usage, tolerance and other measures on healthy volunteers.
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Ninety people were involved in the test of the unidentified drug, used to treat anxiety or pain tied to degenerative illnesses.
The trial began January 7.
Reports also show that initial trials on lab animals now do not offer any clues on what may have caused this accident which is being described as one of the most troubling medical incidents in France.
French clinical research group Biotrial insists that it carried out the trial, which is now suspended, “in full compliance with global regulations”, but The National Agency of Drug Safety has now launched its own investigation into the incident. All of them were part of a drug test of Bial drug.
Neuroscience chief Gilles Edan said Friday that one of the men had not yet shown symptoms but was being held for monitoring.
A French hospital says a patient has died after taking part in an experimental drug trial, and five other participants remain hospitalized.
The patient had already been declared brain dead following the trial for a painkiller based on a compound similar to the active ingredient in marijuana.
While this drug is listed as being in phase 1 testing – which assesses a drug’s safety – on BIAL’s Pipeline list, the pharmaceutical company and Biotrial have not confirmed this to be true.
Clinical trials are the key to getting that data – and without volunteers to take part in the trials, there would be no new treatments for serious diseases such as cancer, multiple sclerosis and arthritis.
According to the press release, the hospitalized volunteers had received the medication in higher doses. Touraine added that the drug molecule had previously been tested on chimpanzees.
Accidental deaths from Phase 1 of clinical trials are said to be quite rare.
He was among six male volunteers taken to hospital last week after receiving the experimental drug.
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Brain scans show 4 volunteers may have suffered serious neurological damage, and the hospital says there is no treatment to reverse their side effects.
