Cortech Inc. has joined the parade of biotechnology companiesfrustrated in attempts to develop drugs for treatment of sepsis, a deadlybacterial blood infection that kills more than 70,000 people a year inthe U.S.The news sent Cortech's stock (NADSAQ:CRTQ) plummeting bymore than 60 percent, closing Friday at $2.25 a share, down $3.87.The Denver-based company said preliminary results from its firstPhase II trial of Bradycor, a bradykinin antagonist, showed nosignificant reduction in 28-day mortality for patients with systemicinflammatory response syndrome and sepsis.Based on the findings, Timothy Rodell, executive vice president ofoperations and product development, said Friday the company will notstart a Phase III trial.For now, Rodell said, Cortech will continue on a second Phase IIstudy, which is to be completed by the end of the year. That trialinvolves 100 patients who will receive the drug over seven dayscompared with the first 500-patient, three-day study."We have not discontinued the on-going seven-day trial," he said. "Wehave to evaluate all the data from the three-day trial and we have toevaluate the likelihood the seven-day trial will yield more meaningfulresults."Another company, Scios Nova Inc., of Mountain View, Calif., saidFriday it decided not to pursue human clinical trials for a sepsistreatment following poor pre-clinical trials of its bradykininantagonist.Cortech and Scios Nova are just two among many companiesfrustrated by the complex blood infection. Last Monday, SynergenInc., of Boulder, Colo., ended its efforts to develop Antril, aninterleukin-1 receptor antagonist, to treat sepsis. (See BioWorldToday, July 19, p. 1.)Others whose sepsis trials have experienced disappointing resultsinclude Centocor Inc., of Malvern, Pa., Chiron Corp., of Emeryville,Calif., Xoma Corp., of Berkeley, Calif., and Immunex Corp., ofSeattle.Xoma is conducting a redesigned clinical study with the samecompound that failed in earlier trials and Chiron and Synergen areinvolved in additional studies with different compounds.Other companies still conducting clinical trials for sepsis includeBritish Biotechnology Group plc, of Oxford, England; RibiImmunoChem Research Inc., of Hamilton, Mont.; and Celltech Groupplc, of London.Those with pre-clinical research under way include IncytePharmaceuticals Inc., of Palo Alto, Calif.; ImClone Systems Inc., ofNew York; Vertex Pharmaceuticals Inc., of Cambridge, Mass.; andUnivax Biologics Inc., of Rockville, Md.Rodell said the poor performance of Bradycor for sepsis will not resultin any layoffs and will not affect other programs involving the drug.Phase II trials of Bradycor are under way for patients with headinjuries, burns, multiple trauma and hantavirus.Rodell suggested one problem facing companies in developing sepsisdrugs may be an overly ambitious goal; that is, the reduction of 28-day mortality."We should be looking at endpoints closer to the mechanism of thedrugs, such as the effects on organ failure, time in the intensive careunit and short-term [14 days or less] mortality," he said. n

-- Charles Craig

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