ProFibrix Reports Phase II Results of Hemostasis Product Fibrocaps(TM)
LEIDEN, THE NETHERLANDS and SEATTLE, WA - ProFibrix B.V., a leader in the development of innovative products for hemostasis and regenerative medicine, today announced the conclusion of the first Phase II trial testing its unique new hemostat Fibrocaps. 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 unique characteristics and demonstrates optimal efficacy. We are fully committed to assist ProFibrix with the further development of this product and look forward to bringing this important innovation in hemostasis to the clinic.”
ProFibrix recently also appointed Paul A. Frohna, MD, PhD, as Chief Medical Officer. Dr. Frohna has extensive preclinical, clinical and regulatory experience, as well as with designing and running clinical trials in the U.S., Canada and Europe. He has held senior management positions at companies such as Fibrogen Inc., CV Therapeutics, and Genentech. Dr. Frohna's educational background includes an undergraduate pharmacy degree with Honors from the University of Texas at Austin College of Pharmacy, a PhD in Pharmacology from the University of Pennsylvania School of Medicine, and an MD from Georgetown University Medical School.
Jan Ohrstrom, COO and President of ProFibrix Inc said: “We are very pleased with the successful conclusion of our Phase II Fibrocaps trial. It provides us with an excellent basis for the large Phase II study that we intend to initiate in the U.S. and the EU early in Q3, 2010, after IND filing. We are also happy to announce the appointment of Paul Frohna as Chief Medical Officer. Paul has a wealth of experience in all areas of clinical research, has intimate knowledge of the hemostasis field, and will be instrumental 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 sealant that rapidly stops bleeding after or during surgery. Fibrocaps has major advantages over existing liquid tissue sealants: it is ready for immediate use, is stable at room temperature, highly effective and fast acting.
ProFibrix (www.ProFibrix.com) was founded in 2004 and is headquartered in Leiden, The Netherlands, with a subsidiary in Seattle, WA, USA. The company leverages its expertise in fibrinogen technology to develop and market innovative products for the hemostasis and regenerative medicine markets. Human fibrinogen plays a pivotal role in blood clotting and tissue healing. ProFibrix is led by a team with extensive commercial, clinical and scientific experience in the hemostasis field.