Cortech Inc. has filed an amendment to its investigational new drugapplication (IND) to begin a second Phase II trial of its drug, Bradycor,in the treatment of systemic inflammatory response syndrome (SIRS)and suspected sepsis. Bradycor will be administered for seven days inthe new trial, compared to three in the trial that has just ended.Bradycor blocks the action of bradykinin, a peptide that is generated inresponse to injury and mediates pain, endothelial cell damage,hypotension and edema.Christi Foster, the Denver - company's director of communications,said the new trial was prompted by the conclusions of sepsis trialsconducted by other companies, and not by concern about possiblefindings of the first Phase II trial."We have been thinking about doing this for a while, " Foster said."The three-day trial results are still blinded and we don't have anyinformation about it. However, in sepsis trials conducted by othercompanies, a number of people died in day five, six or seven aftertreatment. So we decided to extend the treatment period for the secondtrial to seven days. These results will help us design the Phase III trial."The second trial will enroll 100 patients in 10 centers, compared to thefirst Phase II trial which involved 500 patients at 47 sites.Cortech's stock closed at $8.75, up $1. Wole Fayemi, a seniorbiotechnology analyst with Hambrecht and Quist of New York, said heviewed the company's decision as a moderate to positiveannouncement. "They are looking at refining the dosage regimen," hesaid. "There's a lot of evidence that increasing the length of the infusioncould increase the survival rate of patients. This is a final chance toidealize the dose before Phase III. It's a smaller trial and should notmean that the start of the Phase III trial is delayed." _ Philippa Maister
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