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news.Ipsen's partner, Inspiration Biopharmaceuticals has commenced the second phase III pivotal clinical study of OBI-1 in congenital hemophilia A with inhibitors.
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OBI-1, an intravenous recombinant porcine factor VIII (FVIII) product which shows low cross reactivity to antihuman FVIII antibodies, is a replacement therapy, activating the intrinsic hemostatic pathway.
The OBI-1 second phase III pivotal clinical study is a non-randomized, open-label study investigating the efficacy of OBI-1 to treat serious bleeding episodes.
The first pivotal study of OBI-1 for the treatment of severe bleedings in individuals which began in November 2010 demonstrated positive data.
Ipsen Chairman and CEO Marc de Garidel said the commencement of the second OBI-1 phase III clinical trial is a key step towards advancement of their hemophilia franchise.
"We are pleased with the progress made by Inspiration who initiates in due time the second OBI-1 phase III clinical trial after having filed a Marketing Authorization Application in Europe for IB1001, a recombinant factor IX," Garidel added.