Second of Three Planned Safety Analyses Successfully Completed
Aachen (Germany), 25 July 2006 - Biopharmaceutical company PAION AG (Frankfurt Stock Exchange, Prime Standard: PA8), today confirmed that the ongoing Phase III 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 (sICHs) - which is a major concern of treating physicians - has been below predefined levels.
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 enrol 186 patients in 80 centres worldwide who are treated within 3 to 9 hours after the onset of acute ischaemic stroke. The only clot-busting drug approved today has a label limited to application within 3 hours after stroke onset. Thus, significantly widening that time window with PAION's Desmoteplase to 9 hours would greatly enhance eligibility of causal treatment for stroke patients.
"Thanks to the enthusiastic and diligent effort of our study investigators we currently have already achieved almost two third of the enrolment completed", comments Dr Mariola Soehngen, PAION's Chief Medical Officer. "Given the recent recruitment rate we feel confident that we will complete enrolment on time by the end of this year. Under this timeframe we would expect topline results to be available not later than mid-year 2007."
About stroke Stroke is the third leading cause of death in the industrialised world and a leading cause of serious, long-term disability. In the US alone, 700,000 people suffer from a stroke attack each year, and around 20% of them die within four weeks. For the US, the American Stroke Association expects the financial burden of stroke due to in-hospital costs, long-term care programs and productivity losses to be 58 billion dollars in 2006 alone.
About Desmoteplase Desmoteplase, the most specific plasminogen activator known today, is a genetically engineered version of a clot-dissolving protein found in the saliva of the vampire bat Desmodus rotundus. Currently in Phase III, Desmoteplase was successfully tested in two independent Phase II studies for the treatment of acute ischaemic stroke between 3 and 9 hours after onset of symptoms and has received fast-track designation from the U.S. Food and Drug Administration for the indication of acute ischaemic stroke. Desmoteplase is partnered with Forest Laboratories, Inc. and H. Lundbeck A/S.
About PAION PAION is a public biopharmaceutical company based in Aachen, Germany (Frankfurt Stock Exchange, Prime Standard, ISIN DE000A0B65S3). It aims to become a leader in developing and marketing innovative drugs for the treatment of stroke and other thrombotic diseases for which there is a substantial unmet medical need. PAION's activities are focused on the development of the three drugs Desmoteplase, Enecadin and Solulin. Currently PAION employs more than 75 people.
Contact Dr. Peer Nils Schroeder, Investor Relations / Public Relations PAION AG Martinstrasse 10-12 52062 Aachen - Germany Tel. +49 (0)241 4453 152 Email [email protected] www.paion.de
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