Cortech Inc. has filed a revised analysis plan with the FDA forits Phase II study of Bradycor in patients with systemicinflammatory response syndrome (SIRS) and suspected sepsis,based on a risk model derived from the APACHE III data base.
Developed over 15 years of analysis of more than 100,000patients, APACHE is an accepted scoring system for critically illpatients. The APACHE III Sepsis Risk Model will allow Cortechto measure the effect of Bradycor on patients according to theirindividual, prospective risk of mortality.
"This variability in the patient's risk of mortality can lead tovariability in the drug response," said Timothy Rodell, seniorvice president of operations and product development atCortech (NASDAQ:CRTQ) of Denver.
"Without the power to detect and correct for variability in risk,a positive effect of the drug can be obscured," he continued."However, this analysis obviously cannot change whether ornot the drug works."
Bradycor is currently being studied in a double-blind, placebo-controlled study that will enroll 500 patients with SIRS andsuspected sepsis. The drug blocks bradykinin, a peptide thatmediates pain, endothelial cell damage, low blood pressure andfluid buildup.
"Even if the results of this study are positive," Rodell said, "wewould still expect to perform an additional confirmatory studyprior to NDA (new drug application) submission." -- NancyGarcia
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