Cortech has presented equivocal data resulting from three additional analyses of its first Phase II sepsis trial with Bradycor (its bradykinin antagonist). These included analyses of subgroups by infectious organism, 28-day mortality in patients with a greater than 25% risk of dying at baseline and changes in the APACHE III Acute Physiology Score.
In the first analysis, a subgroup of 112 patients with sepsis caused by Gram-negative organisms, showed a 19% improvement in survival at 28 days and a statistically significant improvement in risk-adjusted survival over 28 days (p=0.005). In the subgroup with Gram-positive infections there was no trend towards increase in survival or decrease in survival. The second analysis showed a trend towards survival in patients with a greater than 25% risk of dying but this did not reach significance. The final analysis again showed a trend towards improvement on the APACHE III scale but it did not reach statistical significance.
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