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Home Industry News PAION reports Phase III data

PAION reports Phase III data

18th October 2007

PAION has reported the findings from a Phase III study of Desmoteplase, indicated for use in acute ischemic stroke.

The Phase III stroke study DIAS-2 showed that Desmoteplase did not meet its primary efficacy end points due to a lack of improvement in the Desmoteplase groups compared to a placebo.

While this was in contrast to the previous Phase II studies, the clinical efficacy of Desmoteplase could not be confirmed.

The patient subgroups in the DIAS-2 study did however generate new findings relating to the unpredictably high placebo rate and provides indication for the efficacy of Desmoteplase despite the limited statistical significance as a result of the small patient numbers in the subgroups.

“We have identified probable reasons for the unexpectedly good outcome in the placebo arm as well as variables that will help optimise patient selection” stated Dr Werner Hacke and Anthony J Furlan, chairmen of the DIAS-2 steering committee. “Therefore, we see a scientific rationale to move on to the next study.”

Chief executive officer of PAION Dr Wolfgang Sohngen also indicated that the results demonstrated “sound development” for Desmoteplase and that future trials were being proposed.

PAION is a biopharmaceutical company based in Aachen, Germany, developing and commercialising innovative drugs for the treatment of stroke and other thrombotic diseases.

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