Chiron Announces Results of Phase III Study of Tifacogin in Severe Sepsis
EMERYVILLE, Calif., Nov. 21 /PRNewswire/ -- Chiron Corporation (Nasdaq: CHIR - news) announced today the results of its Phase III trial, OPTIMIST, for the evaluation of tifacogin in severe sepsis. The results from the trial indicate that tifacogin did not meet the primary endpoint of reducing 28-day all-cause mortality. There were no safety issues identified in tifacogin-treated patients.
``We have always recognized the challenges of developing a therapeutic for severe sepsis,'' said Sean Lance, chairman and chief executive officer of Chiron. ``We will be undertaking a full review of the data from the Phase III trial, and we will make future development decisions about tifacogin after we have completed the analysis of the data.''
Sepsis is a disease syndrome defined by a systemic response to an infection that frequently leads to multiple-organ failure and death. Distinguishing features of the syndrome include a drop in blood pressure, increase in body temperature, exaggerated inflammatory response and abnormal clotting. Approximately 30 percent to 50 percent of those who develop severe sepsis die.
Tifacogin, which is being developed by Chiron and Pharmacia Corporation in partnership, is a recombinant form of tissue factor pathway inhibitor, or TFPI. TFPI, which is normally produced by the body, inhibits a key step in blood coagulation that ultimately leads to clot formation. By blocking the formation of the clots and attenuating the exaggerated inflammatory response associated with the disease, TFPI is thought to lead to the prevention of multiple-organ failure, a major cause of death in severe sepsis.
The OPTIMIST trial was a prospective, double-blind, placebo-controlled trial investigating the use of tifacogin in the treatment of severe sepsis in patients. The trial included approximately 2,000 patients from 16 countries who were randomized to receive either placebo or tifacogin. The primary endpoint of the study was a reduction in 28-day all-cause mortality. |
