Bat Saliva-Based Stroke Drug Disappoint... (nine hours with desmoteplase. But th...)

Bat Saliva-Based Stroke Drug Disappoints in Trial

Date:12/18/2008

nine hours with desmoteplase."

But the strategy didn't work in DIAS-2, which included 186 people with strokes. A total of 123 patients received either a high or low dose of desmoteplase, while 63 got a placebo.

The death rate was actually higher for those who got the drug -- 11 percent in the low-dose group and 21 percent in the high-dose group, compared to 6 percent for those given a placebo.

So it's back to the drawing board, the researchers said, and one big question is whether the high-tech methods used to select participants in the trial were too sophisticated to be reliable.

DIAS-2 neurologists used either computerized tomography or magnetic resonance scanning to detect what they formally called "mismatches" -- brain areas that have been affected by the stroke but are not yet dead.

"There is a core area of tissue that is dead," Furlan explained. "Around that area are brain cells that are not yet dead, so they can be saved."

That is the theory, anyway. But it's a theory that some of the neurologists involved with the new drug are questioning.

"The current mismatch model is insufficient to identify those patients who would benefit," Furlan said. "We need a more sophisticated mismatch model."

But another school of thought among neurologists is that a simpler, rather than more complex, method of choosing trial participants might be better.

"There is some controversy about the design of the next trial," Furlan said. "Maybe we can select patients simply by determining whether a major artery is blocked, instead of the mismatch. The main way patients would be enrolled is by looking to see if a major artery is blocked out to nine hours, rather than for mismatch."

No firm start date has been set for DIAS-3, said Furlan, who is on the safety committee for the proposed trial.

The trial was funded by German drug company PAION Deutschland GmbH and U.S.-based Forest
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