12:00 AM
 | 
Jun 04, 2007
 |  BioCentury  |  Product Development

Desmoteplase: Not much to go on

While it's not clear what caused last week's failure of the Phase III DIAS-2 trial of Paion AG's desmoteplase to treat acute ischemic stroke, small patient numbers and the lack of a reperfusion endpoint might make it impossible to assess whether the thrombolytic works or not. As a result, Paion estimates that potential approval has been pushed back at least two years.

Paion and partner Forest Laboratories Inc. reported that both doses of desmoteplase missed the primary endpoint of clinical improvement at day 90 vs. placebo in DIAS-2, the same endpoint that was met in the similarly designed Phase II DIAS and DEDAS trials.

"The design and size of the Phase III was based on two Phase II trials, which showed a benefit in the treatment groups," Paion CEO Wolfgang Soehngen said on a conference call, "and so the major issue was that the placebo response rate kind of exploded in the Phase III trial."

"Even in bigger trials, you can not definitely prevent this, but with higher patient numbers, you have a chance that this is less of a problem," he told BioCentury.

DIAS enrolled 104 patients, and DIAS-2 enrolled 186. The sample size for DIAS-2 was calculated to detect with 80% power a difference in clinical improvement of 25% between both dose groups and placebo, given a rate of 20% in the placebo group.

Both trials tested 90 and 125 µg/kg of desmoteplase, and both defined clinical improvement as a patient meeting three criteria: an improvement of...

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