2011-03-08

ProFibrix Initiates Phase II With Lead Hemostasis Product Fibrocaps(TM) in US and Europe


Leiden, The Netherlands and Seattle (ots/PRNewswire) -ProFibrix B.V., a leader in the development of innovative productsfor hemostasis, today announced that it has initiated a prospective,multi-center Phase II study with its lead product Fibrocaps at up to20 sites, including major U.S. and Dutch academic medical centers.

Jaap Koopman, CEO of ProFibrix said: "The start of this largePhase II study in multiple surgical indications is a major milestonein the rapid development of our lead product Fibrocaps. If, as weexpect, this study confirms the positive results of our first PhaseII trial, we anticipate initiating a pivotal Phase III trial in early2012, which puts us on track for a BLA filing early 2013."

About Fibrocaps

Fibrocaps is based on a mixture of two essential blood clottingproteins, fibrinogen and thrombin, and is a unique dry powder topicalfibrin sealant being developed to stop bleeding during or aftersurgery. Fibrocaps is clearly differentiated from existing liquidtissue sealants and hemostats: it is ready for immediate use, and isstable at room temperature.

About the Study

The second Phase II clinical trial of Fibrocaps (FC002) in theU.S. and Europe builds on the success of ProFibrix's first Phase IIstudy at a number of European centers, which demonstrated acompelling safety and efficacy profile for Fibrocaps. The currentPhase II trial is a prospective, randomized, single-blind, controlledstudy. The study sites include up to 20 major academic and leadingprivate medical centers in the U.S. and Europe. Apart from measuringoverall safety , the primary efficacy endpoint of the study is themean time to hemostasis (TTH) of Fibrocaps versus control.Approximately 130 patients will be randomized across four differentsurgical indications: peripheral vascular surgery, spinal surgery,liver resection surgery and soft tissue dissection. Completion of thestudy is expected in the third quarter of 2011.

To allow ProFibrix to conduct the Fibrocaps Phase II clinicaltrial in the U.S., the company filed an Investigational New Drug(IND) application with the U.S. Food and Drug Administration.Following review by the Agency in December 2010, the IND is now openand ProFibrix has started enrolling patients at the participatingcenters in the U.S. and EU. For more details on the study, please goto http://www.clinicaltrials.gov.

About ProFibrix

ProFibrix (http://www.profibrix.com) was founded in 2004 and isheadquartered in Leiden, The Netherlands, with a subsidiary inSeattle, WA, USA. The company leverages its expertise in fibrinogentechnology to develop and market innovative products for thehemostasis and regenerative medicine markets. Human fibrinogen playsa pivotal role in blood clotting and tissue healing. ProFibrix is ledby a team with extensive commercial, clinical and scientificexperience in the hemostasis field.

ots Originaltext: ProFibrix BVIm Internet recherchierbar: http://www.presseportal.de

Contact:ProFibrix B.V., Jaap Koopman, Ph.D., CEO, Tel: +31-(0)6-21628475,E-mail: j.koopman@profibrix.com. ProFibrix Inc., Jan Ohrstrom, MD, COO,Tel: +1-2069105404, E-mail: j.ohrstrom@profibrix.com

ProFibrix BV

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ProFibrix Initiates Phase II With Lead Hemostasis Product Fibrocaps(TM) in US and Europe

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