Cortech Inc. late Tuesday released Phase II data showingits drug Bradycor failed to reduce 28-day mortality inpatients with systemic inflammatory response syndrome(SIRS) and sepsis. In fact, mortality was higher in thedrug-treated group.

The results followed by one year disappointing data fromthe Denver company's first Phase II trial of thebradykinin antagonist for sepsis. Those data, which alsofailed to show statistical significance in 28-day mortality,caused the company's stock (NASDAQ:CRTQ) toplummet 63 percent, to $2.25 per share.

The second trial, started in May 1994, involved 251patients who got seven-day infusions of Bradycor orplacebo, rather than three-day infusions as in the first504-patient study. Mortality in the second trial, with agroup of 167 patients who received Bradycor, was 37percent, which was higher than the 29 percent in theplacebo group of 84.

In addition, the second trial failed to confirm a positiveeffect on mortality in a subgroup with Gram-negativeinfections. A subsequent analysis of 112 patients from thefirst trial showed a statistically significant improvementin risk-adjusted survival over 28 days.

The positive data gleaned in the Gram-negative subset ledCortech officials to expand the second trial from 100patients to 251 so the subset data would provide moredefinitive results.

Cortech said it is stopping enrollment in three other trialsof Bradycor until it determines why additional mortalitywas seen in the drug group vs. the placebo group. Phase IItrials of Bradycor were put on hold in traumatic braininjury, multiple trauma and hantavirus infection. Thehantavirus indication essentially was already stopped forlack of patients, said Christi Foster, director ofcommunications for Cortech.

"We don't know whether the effect is drug related andwhether it's going to carry over into other indications,"Foster told BioWorld. "It may just be statistics, but wedon't know that it's not drug related. The whole things isup in the air until we understand the data." She saidanswers should be available in a few months.

Cortech joins a long list of companies that have failed intheir attempts to find a drug that works against sepsis, abacterial blood infection that kills more than 70,000people per year in the U.S. Others with disappointingclinical results over the past few years include SciosNova Inc., of Mountain View, Calif.; Synergen Inc., ofBoulder, Colo.; Centocor Inc., of Malvern, Pa.; ChironCorp., of Emeryville, Calif.; Xoma Corp., of Berkeley,Calif.; and Immunex Corp., of Seattle.

Cortech has been seeking partners for Bradycor. Thetraumatic brain injury study, designed to enroll 160patients, was just recently started. The multiple traumastudy was designed to enroll 140 patients, with an interimlook taken at the halfway point. Foster said that trial wasvery close to that point. Each is on hold, she said.

Cortech's stock didn't trade Tuesday because of theexpected release of the trial results. It closed Monday at$3.63 per share. Cortech reported on March 31 havingabout 18 million shares outstanding and $34 million incash and equivalents. Its net loss in the first quarter was$5.8 million. At that rate, the company has about oneyear's worth of cash. n

-- Jim Shrine

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