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news.Forest Laboratories has begun a phase IIb/III study of desmoteplase, a novel investigational treatment for acute ischemic stroke developed by Paion GmbH and based on an agent found in vampire bat saliva.
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The study, named DIAS2, will be a multinational, randomized, parallel-design dose-ranging study to confirm the results of earlier phase II studies. These studies demonstrated the potential of desmoteplase to treat acute ischemic stroke patients up to nine hours after the onset of stroke symptoms, three times longer than the currently available treatment allows.
Results from the recently completed DEDAS study showed trends indicating that desmoteplase improved blood flow in the damaged area of the brain and improved clinical outcome after 90 days compared to placebo.
Desmoteplase, first in a new class of plasminogen activators, is a genetically engineered version of a clot-busting agent found in the saliva of the vampire bat, Desmodus rotundus.
Desmoteplase was licensed to Forest by Paion GmbH in 2004. Under the agreement, Forest will be responsible for regulatory and sales and marketing activities in the US and Canada, and will have development and marketing rights to other indications in these territories. Paion retains commercial rights in Europe, Japan, and the rest of the world.