Cortech Inc.'s stock on Wednesday took its second hitfrom a failed trial of Bradycor for sepsis, falling 59percent on the news announced late Tuesday. (SeeBioWorld Today, July 19, p. 1.)

The stock (NASDAQ:CRTQ) fell from $3.63 to $1.50 intrading of nearly 1.6 million shares. One year ago thestock dropped 63 percent, to $2.25, when the Denvercompany's first trial of Bradycor in sepsis failed to showa reduction in 28-day mortality.

An analyst and a company official each pointed to acurious aspect of the new trial data _ that the mortalityrate in the placebo group was 29 percent, well underhistorical controls. But both said that aberration doesn'tmean the drug had effect on the deadly bacterial bloodinfection.

Barbara Hoffman, an independent analyst with Denver-based Hoffman & Co., told BioWorld the market reactionlikely was a result of a misunderstanding about potentialsafety issues with the drug, and not the failed trial, whichlargely was expected.

"This is a bit of an overreaction," Hoffman said of thestock drop. "What you see in the placebo death rate is aprofound sampling error." She said a mortality rate of 35to 45 percent should have been expected, and the lowernumber is attributable to the small placebo patient size.

The trial, begun in June 1994, enrolled 251 patients at 13U.S. centers. Patients were treated with either a seven-dayinfusion of Bradycor or placebo and monitored for 28days. The drug group had 167 patients. There were 84 inthe placebo group.

Timothy Rodell, Cortech's executive vice president ofoperations and product development, told BioWorld thatBradycor has been tested in about 600 humans withoutany evidence of adverse events as seen in the secondPhase II sepsis trial.

"My hope, and my belief, is that any potential partnerwould view this in the same way we would, that it doesnot have an impact on the utility of the drug or the abilityto develop it for other indications," Rodell said. "Ourpartnering strategy is not dependent on success in sepsis."

That strategy is more geared toward development of thebradykinin antagonist for traumatic brain injury, Rodellsaid. Cortech has put on hold ongoing Bradycor trials inthat indication and in multiple trauma while it makes sure"the trend toward excess mortality [in the sepsis trial]does not present a significant risk to patients in our otherstudies," he said.

Rodell said Cortech should be able to put together ananalysis of the data fairly quickly, then would have tomeet with the FDA before resuming Phase II trials inother indications. The traumatic brain injury trial,designed to enroll 160 patients, recently was started. The140-patient multiple trauma study was near its halfwaypoint when put on hold. An interim analysis will be madesoon after the multiple trauma trial resumes.

Rodell said Cortech, like many companies before it, willdiscontinue development of the drug for sepsis. He madetwo observations on the disease: It's difficult to study,and any agent that may have activity probably won't havehuge impacts on mortality. "That means it's going to takelarge studies to demonstrate the activity of a drug," hesaid.

Rodell said Cortech has adequate cash to get into 1997,assuming adjustments are made to the burn rate. Themost important adjustment, he said, would involve apartnership for Bradycor. n

-- Jim Shrine

(c) 1997 American Health Consultants. All rights reserved.