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Joint analysis of two Phase II studies with Desmoteplase
presented at the European Stroke Conference
Confirmatory study DIAS-2 started to confirm 3-9 hour treatment time window
Aachen, Bologna, 30 May 2005 –
The joint analysis of DIAS and DEDAS, two Phase
II studies sponsored by PAION that examined the investigational novel plasminogen
activator Desmoteplase in the treatment of acute ischaemic stroke was presented at
the European Stroke Conference in Bologna on 28 May, 2005. The analysis confirms
the positive results of the individual studies.
DIAS and DEDAS were placebo controlled, double blind, multi-centre and multinationaldose finding Phase II safety studies. Patients were diagnosed with magneticresonance imaging. Altogether 142 acute ischaemic stroke patients were randomizedin the US, Europe and AustralAsia within three to nine hours from the onset of strokesymptoms. The joint analysis includes all patients treated with either placebo, 90µg/kgor 125µg/kg (N=94). Main efficacy endpoints were the rate of reperfusion and positiveclinical outcome after 90 days.
The combined rate of intracranial bleeding for the doses of 90µg/kg and 125µg/kgDesmoteplase was 1.7% (1 patient in the 90µg/kg group). Mortality was generally low:5.7% on placebo, 6.9% on 90µg/kg and 3.3% on 125µg/kg. The reperfusion rates were23.5% on placebo, 34.6% on 90µg/kg and 62.1% on 125µg/kg. Positive clinicaloutcomes at day 90 were 22.9% on placebo, 37.9% on 90 µg/kg and 60% on 125µg/kg.
Prof. Dr. Werner Hacke, principal investigator of DIAS, presenting the joint analysis,said: “Successful treatment in the time window beyond 3 hours is urgently needed, asthe number of patients arriving that early is still low. Desmoteplase may be a treatmentoption for patients that arrive later”.
“These very positive results show that we are on the right track with Desmoteplase andnow after two independent studies we are optimistic that these results will beconfirmed in a larger study, DIAS-2, also using perfusion CT for diagnosis”, commentsDr. Mariola Söhngen, CMO of PAION.
DIAS-2 (Desmoteplase in Acute Ischemic Stroke) aims to confirm the 3-9 hourtreatment time window in ischaemic stroke with Desmoteplase in a larger number ofpatients. Conducted jointly by PAION and Forest Laboratories, Inc., it is a multi-centre,multinational, randomized, parallel-design dose-ranging study (90µg/kg, 125µg/kg,placebo) with about 60 participating hospitals in Europe, USA, Canada andAustralAsia. Perfusion computer tomography (pCT) and magnetic resonance imaging(MRI) will both be allowed as a diagnostic tool for the identification of patients who maybenefit from reperfusion therapy (restoration of blood flow) with Desmoteplase.
About Desmoteplase and Stroke
Desmoteplase, first in a new class of plasminogen activators, is a genetically engineered
version of a clot-dissolving protein found in the saliva of the vampire bat Desmodus rotundus. It
possesses high fibrin selectivity, allowing it to dissolve a clot locally without affecting the blood
coagulation system, which is thought to potentially reduce the risk of intracranial bleeding (a
common risk when administering blood clot-dissolvers) as compared to less fibrin-specific
Stroke is the third leading cause of death in the industrialised world after heart disease andcancer. The treatment of acute stroke and related serious long-term disabilities currentlyrepresent a substantial unmet medical need. The only drug currently approved for the treatmentof acute ischaemic stroke must be administered within three hours after the onset of strokesymptoms, which limits the potential patient population that can safely benefit from the rapiddissolution of the blood clot and the restoration of blood supply to the affected area of the brain.
PAION, a biopharmaceutical company based in Aachen, Germany, aims to become a leader in
developing and commercialising innovative drugs for the treatment of stroke and other
thrombotic diseases for which there is a substantial unmet medical need. PAION intends to
build an integrated portfolio of drugs by exploiting its core expertise in identifying compounds
with potential in the treatment of stroke and other thrombotic diseases, licensing or otherwise
acquiring these compounds and advancing them through the clinical development and
regulatory approval process. PAION’s most advanced drug candidate, Desmoteplase, has
received fast-track designation from the U.S. Food and Drug Administration for the indication
acute ischemic stroke. PAION currently employs approximately 56 people. In February 2005
PAION conducted an IPO at the Frankfurt Stock Exchange (stock symbol PA8, ISIN:
DE000A0B65S3). More information is available at www.paion.de.
About Forest Laboratories and Its Products
Forest Laboratories' growing line of products includes: Lexapro® (escitalopram oxalate), an
SSRI antidepressant indicated for the initial and maintenance treatment of major depressive
disorder and for generalized anxiety disorder in adults; Namenda® (memantine HCl), an N-
methyl-D-aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate to
severe Alzheimer's disease; Benicar®* (olmesartan medoxomil), an angiotensin receptor
blocker indicated for the treatment of hypertension; Benicar* HCT® (olmesartan medoxomil
hydrochlorothiazide), an angiotensin receptor blocker and diuretic combination product
indicated for the second-line treatment of hypertension; Campral®* (acamprosate calcium), a
glutamate receptor modulator, indicated for the maintenance of abstinence from alcohol in
patients with alcohol dependence who are abstinent at treatment initiation in combination with
psychosocial support; and Combunox™ (Oxycodone HCl and Ibuprofen), an opioid and NSAID
combination indicated for the short-term management of acute, moderate to severe pain. More
information is available at www.frx.com.
*Benicar® is a registered trademark of Sankyo Pharma, Inc
Dr. Peer Nils Schroeder (Investor Relations / Public Relations)
PAION AG, Martinstr. 10-12, 52062 Aachen,
Tel: +49-(0)241-44-53-152, firstname.lastname@example.org
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