LEIDEN, The Netherlands and SEATTLE, Washington, March 11, 2010 ProFibrix B.V., a leader in the development of innovativeproducts for hemostasis and regenerative medicine, today announced theconclusion of the first Phase II trial testing its unique new hemostatFibrocaps(TM). Promising preliminary data from the European multicenter,open-label trial show compelling safety and efficacy (time to hemostasis)profiles for Fibrocaps, and good performance of the delivery device.
Robert J. Porte, MD, PhD, principal investigator of the Phase II trial,said: "Fibrocaps is a highly promising new hemostat that has uniquecharacteristics and demonstrates optimal efficacy. We are fully committed toassist ProFibrix with the further development of this product and lookforward to bringing this important innovation in hemostasis to the clinic."
ProFibrix recently also appointed Paul A. Frohna, MD, PhD, as ChiefMedical Officer. Dr. Frohna has extensive preclinical, clinical andregulatory experience, as well as with designing and running clinical trialsin the U.S., Canada and Europe. He has held senior management positions atcompanies such as Fibrogen Inc., CV Therapeutics, and Genentech. Dr. Frohna'seducational background includes an undergraduate pharmacy degree with Honorsfrom the University of Texas at Austin College of Pharmacy, a PhD inPharmacology from the University of Pennsylvania School of Medicine, and anMD from Georgetown University Medical School.
Jan Ohrstrom, COO and President of ProFibrix Inc said: "We are verypleased with the successful conclusion of our Phase II Fibrocaps trial. Itprovides us with an excellent basis for the large Phase II study that weintend to initiate in the U.S. and the EU early in Q3, 2010, after INDfiling. We are also happy to announce the appointment of Paul Frohna as ChiefMedical Officer. Paul has a wealth of experience in all areas of clinicalresearch, has intimate knowledge of the hemostasis field, and will beinstrumental in running our Phase II and III trials in the U.S. and Europe.He will be based in our Seattle office."
Fibrocaps is based on a mixture of two essential blood clotting proteins,fibrinogen and thrombin, and is a unique dry powder topical tissue sealantthat rapidly stops bleeding after or during surgery. Fibrocaps has majoradvantages over existing liquid tissue sealants: it is ready for immediateuse, is stable at room temperature, highly effective and fast acting.
ProFibrix (http://www.ProFibrix.com) was founded in 2004 and isheadquartered in Leiden, The Netherlands, with a subsidiary in Seattle, WA,USA The company leverages its expertise in fibrinogen technology to developand market innovative products for the hemostasis and regenerative medicinemarkets. Human fibrinogen plays a pivotal role in blood clotting and tissuehealing. ProFibrix is led by a team with extensive commercial, clinical andscientific experience in the hemostasis field.
SOURCE ProFibrix B.V.