The Ministry of Food and Drug Safety said it recently ordered Eutilex to suspend a clinical trial on cell therapy and requested the company to clarify on the credibility of the study.
The ministry had the drugmaker suspend the phase-1/2 trial on “EBViNT Cell,” a treatment for natural killer T (NK/T) cell lymphoma, on Friday.
The government’s inspection of Eutilex from April 11-12 revealed that the initials of a blood donor written on the documents submitted for trial approval were different from those shown during the monitoring. No patient received the experimental treatment.
As one person’s initials among the three blood donors displayed on the pilot products of EBViNT Cell were different from documents for inspection, the ministry suspects that there might be another blood donor who has not been reported to the authorities.
However, Eutilex said on its homepage that “the manual handwriting of raw data had an error on the initials of the blood donor.”
The ministry said the company needs to clarify all the data for the trial including the mislabeling of the initials.
“As the investigation is underway, we can’t comment further. We suspected the credibility of the study data including the initials of the blood donor and suspended the trial,” a ministr official said.
Eutilex was confident to make every issue clear. “It is true that we had three blood donors when we sought approval for the clinical trial. We can demonstrate that we did not omit data of any other blood donor by submitting additional documents,” Eutilex said.
To secure the credibility of the donors, the company is also mulling recreating clinical test samples. It could take about three months to resume the study, assuming conservatively, it said.
With the suspension of Eutilex’ clinical trial, rumors circulated that the food and drug safety ministry might be expanding inspections on biotech firms.
However, the ministry said it did not plan any other inspection, and that no other company had problems in trials.
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