The committee made its recommendation following a planned interim analysis of clinical data from the study in which no safety concerns were identified.
The study is expected to enroll 2,100 patients in 200 centers in 19 countries worldwide, and enrollment is expected to be completed in the first half of 2007. The primary endpoint of the study is reduction in mortality at 28 days.
Tifacogin is a tissue-factor pathway inhibitor (TFPI) that interferes with the increased expression of tissue factor, a protein, which occurs in the lungs of pneumonia patients, where it is believed to directly contribute to activation of blood coagulation and inflammation.
“We appreciate the careful analysis conducted by the committee and their assessment of the study data on tifacogin,” said Dr Stephen Dilly, chief medical officer of Chiron BioPharmaceuticals. “We look forward to a final analysis of the study data.”