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Phase 3 Trial for Tifacogin in Community-Acquired Pneumonia Begins
"The mortality rate associated with severe CAP has remained constant for the past 50 years in spite of significant advances in antibiotic therapy. We believe that tifacogin has the potential to impact this significant unmet medical need," said Dr. Stephen Dilly, chief medical officer of Chiron BioPharmaceuticals. "Tifacogin for severe CAP is an excellent fit with our emerging franchise in serious pulmonary conditions. We have a strong scientific and clinical rationale for this study, which we believe is the right study at the right time for tifacogin."
The Phase III study, called CAPTIVATE, is a randomized placebo-controlled study. The study comprises three treatment arms: placebo, low-dose tifacogin and higher-dose tifacogin. The study is expected to accrue approximately 2,100 patients in 200 centers in 16 countries worldwide. The primary endpoint of the study is reduction in mortality at 28 days.
Severe CAP affects approximately 300,000 patients in the United States annually. Approximately 30 percent of patients with severe CAP die. Current therapy includes routine antibiotics and supportive care. No adjunctive drugs are currently approved for the reduction of mortality in severe CAP.
Source: Chiron Corporation