PAION announces last patient randomized in Phase III ischemic strokestudy (DIAS-2) with Desmoteplase
Aachen (Germany) 8 December 2006 - The biopharmaceutical company
PAION AG (FSE: PA8) announced today that the enrolment of patients in
its stroke study DIAS-2 has been completed.
The primary objective of this randomized, placebo-controlled,
multi-center Phase III study was to investigate improvement of
clinical outcome in patients with acute ischemic stroke. In the time
window of 3 to 9 hours after stroke onset patients received either
placebo or 90mcg/kg, or 125 mcg/kg of Desmoteplase with clinical
outcome measured at 90 days after treatment. 186 patients in Europe,
USA, Canada, Australia, Hong Kong and Singapore were treated in the
study which is jointly conducted by PAION and Forest Laboratories,
Inc. (New York, USA).
"The completion of patient enrolment in the first Phase III study
with our lead drug candidate is a major step forward in the
development programme of this novel plasminogen activator" comments
PAION's Chief Medical Officer Dr. Mariola Soehngen. "Despite the
short recruitment break end of October, we were able to randomize the
last patient according to schedule. We see this as a sign of
confidence in the Desmoteplase development program from our
international group of investigators who were very supportive during
the whole study."
PAION and Forest expect that headline results of the study will be
available by the middle of 2007.
About Desmoteplase
Desmoteplase, the most fibrin-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. It
has received fast-track designation from the U.S. Food and Drug
Administration for the indication of acute ischemic stroke.
About Stroke
According to a recent publication by the American Stroke Association
(ASA), stroke now is the second leading cause of death worldwide and
is a leading cause of serious, long-term disability. In the US alone,
700,000 people suffer a stroke attack each year, and around 20% of
them die within four weeks. For the US, the ASA 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 PAION
PAION is a biopharmaceutical company based in Aachen, Germany (listed
at 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. PAION's most advanced drug candidate, Desmoteplase, is
partnered with Forest Laboratories, Inc. (USA and Canada) and H.
Lundbeck A/S (Europe, Japan, Rest of World). Currently PAION employs
more than 75 people.
Have a nice day
Erbse
