Lundbeck Initiates Clinical Phase III Trials With Desmoteplase in Ischemic Stroke
COPENHAGEN, Dec. 17, 2008--H. Lundbeck A/S has initiated a clinical phase III programme with desmoteplase in the treatment of acute ischemic stroke. The programme consists of two phase III clinical placebo-controlled trials, each enrolling approximately 320 patients.
Today, approximately 80% of stroke patients are not diagnosed and ready for treatment until more than three hours after the stroke takes place. The only currently approved medical treatment for patients suffering from stroke must be applied within a maximum of three hours after the stroke takes place.
Following consultations with health authorities the trials have been designed with the aim of measuring efficacy of one dosage of desmoteplase (90mg/kg) administered in a window of between three and nine hours after the stroke has occurred. The two trials will enrol patients internationally at sites in Europe, USA, Canada, South America and Asia. The efficacy of desmoteplase will be assessed after 90 days.
"Desmoteplase has the potential to treat patients with acute ischaemic stroke up to nine hours after onset of symptoms. That is up to six hours more than existing treatment and will allow a large group of patients time to reach the hospital and be treated", says Executive Vice President Anders Gersel Pedersen, Head of Development at Lundbeck. "Desmoteplase has the potential to become a significant benefit to patients in an area with substantial unmet medical needs."
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 66 billion in 2008.
The content of this release will have no influence on the Lundbeck Group's financial result for 2008.
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Palle Holm Olesen
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Stock Exchange Release No 361 - 17 December 2008
About Lundbeck H. Lundbeck A/S is an international pharmaceutical company engaged in the research and development, production, marketing and sale of pharmaceuticals for the treatment of psychiatric and neurological disorders. In 2007, the company's revenue was DKK 11 billion (approximately EUR 1.5 billion or USD 2.0 billion). The number of employees is approx. 5,300 globally. For more information, please visit www.lundbeck.com.
Posted: December 2008