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