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news.ProFibrix has entered into an agreement with CSL Behring for the clinical and commercial supply of plasma-based fibrinogen and thrombin, for the manufacturing of Fibrocaps.
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Fibrocaps is based on a mixture of two essential blood clotting proteins, fibrinogen and thrombin, and is a dry powder topical tissue sealant in development to stop bleeding after or during surgery.
Fibrocaps is clearly differentiated from existing liquid tissue sealants and hemostats: it is ready for immediate use, is stable at room temperature, and has shown to be safe and efficacious in the first Phase II study conducted in EU. ProFibrix is starting a global Phase II study in the summer of 2010.
CSL Behring is into plasma protein therapeutics industry and a subsidiary of CSL Limited, a global biopharmaceutical company headquartered in Melbourne, Australia.
Jaap Koopman, CEO of ProFibrix said: “The agreement will enable us to use CSL Behring’s fibrinogen and thrombin, approved in markets around the world, as active components in our lead product Fibrocaps. This will offer us a tremendous advantage with regulatory authorities when seeking approval for Fibrocaps.”