Paion's phase 3 stroke trial on target for full enrollment

By Elaine Rigoli

Tampa, Fla., July 25 - Paion AG confirmed that the ongoing phase 3 study DIAS-2 is on target to complete recruitment by the end of 2006.

Additionally, two of the study's three planned interim safety analysis have already been conducted, the second one just recently. No safety concerns were raised by the Data Monitoring Committee, and continuation of the study was approved.

Specifically, the rate of symptomatic bleedings - which is a major concern of treating physicians - has been below predefined levels, the company said in a news release.

The study explores the efficacy of Paion's drug candidate Desmoteplase in acute ischaemic stroke and was started in 2005 together with partner Forest Laboratories, Inc.

It is slated to enroll 186 patients in 80 centers worldwide who are treated within three to nine hours after the onset of acute ischaemic stroke.

The company said the only clot-busting drug approved currently has a label limited to application within three hours after stroke onset.

Paion is a public biopharmaceutical company based in Aachen, Germany.

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