Desmoteplase - acute ischaemic stroke
Desmoteplase was originally found in the saliva of the vampire bat, Desmodus rotundus, where its role consists in supporting the feeding activity of the bat, whose only diet is the blood of mammalians. The protein belongs to a substance class which supports the degradation of blood clots.
Therefore, Desmoteplase could prove useful for the treatment of stroke and other thrombotic diseases, i.e. diseases caused by a blood clot obstructing a vessel.
Stroke is the third leading cause of death in the industrialised world and a leading cause of serious, long-term disability. Each year, three to five out of every one thousand people suffer a stroke in the industrialised world and around 20% of them die within four weeks. One third are permanently dependent on support and care. The financial burden of stroke due to in-hospital, long-term care programs and productivity loss was estimated to amount to 62 billion dollar in 2007 in the US alone.
Desmoteplase has been tested in several clinical studies as a potential therapy for patients with acute ischaemic stroke between three and nine hours after the onset of stroke symptoms. After two positive Phase II studies, the results of a first Phase III study (DIAS-2) revealed no superior efficacy compared to placebo. However, the placebo response rate was extraordinarily high at 46%.
An extended analysis of the data indicated that by selecting a different group of patients (comprising 41% of the patients in the Phase III study) Desmoteplase may indeed prove beneficial. Thus, PAION's partner H. Lundbeck A/S decided to continue the development. Lundbeck holds the exclusive global rights to develop and market Desmoteplase.
In December 2008, Lundbeck initiated a new Phase III program with Desmoteplase. In addition, Lundbeck initiated a Phase II study in Japan (DIAS-J) in March 2010.
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