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news.ProFibrix's multicenter Phase II clinical trial with Fibrocaps in liver resection surgery resulted in a 50% reduction in mean time to hemostasis (TTH) compared to active control..
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Fibrocaps is a dry powder topical fibrin sealant comprising of a mixture of fibrinogen and thrombin blood clotting proteins, which stop bleeding during or after surgery.
The study has enrolled 56 subjects, who have undergone mild to moderate surgical bleeding during liver resection surgery.
The study also demonstrated that Fibrocaps has a very good safety profile.
ProFibrix CEO Jan Öhrström said the positive results ensure that they remain on track to initiate a pivotal Phase III trial in H1 2012, and target a BLA filing in 2013.