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news.Paion, a biopharmaceutical company, has announced that its licensing partner H Lundbeck, a developer and marketer of pharmaceuticals for the treatment of diseases of the central nervous system, has initiated a clinical Phase III program with desmoteplase in the treatment of acute ischemic stroke.
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The program consists of two Phase III clinical placebo-controlled trials, each enrolling approximately 320 patients. The two trials will enroll patients internationally at sites in Europe, the US, Canada, South America and Asia.
Following consultations with health authorities, the trials have been designed with the aim of measuring efficacy of one dosage of desmoteplase (90mcg/kg) administered in a window of between three and nine hours after the stroke has occurred. The efficacy of desmoteplase will be assessed after 90 days.
Anders Pedersen, executive vice president and head of development at Lundbeck, said: “Desmoteplase has the potential to treat patients with acute ischemic 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.”