DGAP-News: PAION'S PARTNER LUNDBECK PRESENTED DATA FROM A POST-HOC ANALYSIS USING DESMOTEPLASE IN ISCHAEMIC STROKE
(firmenpresse) - PAION AG / Research Update
25.02.2010 13:30
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PRESS RELEASE
PAION'S PARTNER LUNDBECK PRESENTED DATA FROM A POST-HOC ANALYSIS USING
DESMOTEPLASE IN ISCHAEMIC STROKE
Aachen (Germany), 25 February 2010 - The biopharmaceutical company PAION AG
(ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) informs
that its licensing partner H. Lundbeck A/S had presented data from a
post-hoc analysis using Desmoteplase in ischaemic stroke at the
International Stroke Conference in San Antonio, Texas.
The findings from the post-hoc analysis of the DIAS-2 trial performed by
PAION provided the basis for the design of the currently ongoing clinical
phase III programme (DIAS-3 and DIAS-4 studies). DIAS-3 and DIAS-4 are
randomized, double-blind, placebo-controlled, multinational phase III twin
trials, aiming to enrol 800 patients with acute stroke. Estimated study
completion is 2011.
You will find further information in the Lundbeck press release published
today under www.lundbeck.com.
###
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.
Patients in an earlier clinical phase III trial with Desmoteplase were
eligible for treatment only in case of a detectable penumbra
(insufficiently perfused but still salvageable tissue area around the
primary location of stroke) of at least 20% of the affected area and were
not screened for presence of vessel occlusion in the larger brain arteries
using angiography. The data from the re-analysis of angiographs from these
patients demonstrated that, in contrast to the phase II studies, 70% of the
patients in the phase III trial lacked visible vessel occlusion before
treatment.
When analysing patient subgroups using presence of vessel occlusion as
treatment criteria, a reduced response rate on the placebo group and a
positive effect of Desmoteplase versus placebo is observed, however not
statistically significant due to the small sample size. Additionally,
pooled results from the clinical phase II and III studies show
statistically significant efficacy in favour of Desmoteplase if patients
without visible occlusions in the large brain arteries are excluded. These
novel findings are encouraging and support continued clinical investigation
in patients with acute ischemic stroke within 3 to 9 hours after onset of
stroke symptoms.
Lundbeck has obtained worldwide rights to Desmoteplase from PAION AG in
Germany. PAION has been supporting in the planning of the new trials.
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,
approximately 700,000 people suffer an ischemic stroke each year, and
around 8-12% of them die within 30 days. For the US, the American Heart
Association estimates the financial burden of stroke due to in-hospital
costs, long-term care programmes and productivity losses to approximately
USD 66billion in 2008.
About PAION
PAION is a biopharmaceutical company headquartered in Aachen, Germany and
has a second site in Cambridge, UK. The company is specialized in
developing and commercializing innovative drugs for the hospital-based
treatment in indications for which there is a substantial unmet medical
need. PAION has a 'Search&Develop' business model, which is based on its
core expertise in drug development. Where appropriate, particularly during
the late stages of the clinical development, PAION seeks to collaborate
with experienced partners.
Contact
Ralf Penner
Director Investor Relations&Public Relations
PAION AG
Martinstrasse 10-12
52062 Aachen - Germany
Phone: +49 241 4453-152
E-mail: r.penner(at)paion.com
www.paion.com
Disclaimer:
This release contains certain forward-looking statements concerning the
future business of PAION AG. These forward-looking statements contained
herein are based on the current expectations, estimates and projections of
PAION AG's management as of the date of this release. They are subject to a
number of assumptions and involve known and unknown risks, uncertainties
and other factors. Should actual conditions differ from the Company's
assumptions, actual results and actions may differ materially from any
future results and developments expressed or implied by such
forward-looking statements. Considering the risks, uncertainties and other
factors involved, recipients should not rely unreasonably upon these
forward-looking statements. PAION AG has no obligation to periodically
update any such forward-looking statements to reflect future events or
developments.
25.02.2010 13:30 Ad hoc announcement, Financial News and Media Release distributed by DGAP. Medienarchiv atwww.dgap-medientreff.deandwww.dgap.de---------------------------------------------------------------------------
Language: English
Company: PAION AG
Martinstr. 10-12
52062 Aachen
Deutschland
Phone: +49 (0)241-4453-0
Fax: +49 (0)241-4453-100
E-mail: info(at)paion.com
Internet: www.paion.com
ISIN: DE000A0B65S3
WKN: A0B65S
Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in Berlin, Düsseldorf, München, Hamburg, Stuttgart
End of News DGAP News-Service
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Datum: 25.02.2010 - 13:30 Uhr
Sprache: Deutsch
News-ID 17116
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