The DSMB recommendation came after a review of available data from the trial, which showed that 28-day mortality in the talactoferrin arm of the study was greater than in the placebo arm.
Agennix decided to unblind the data from the trial to examine better these results. A review will be launched immediately, and the company will decide on its further steps on the development of talactoferrin in severe sepsis only after the completion of the review.
The latest information should have no effect on the conduct of the ongoing FORTIS-M trial with talactoferrin in non-small cell lung cancer.
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