Mar 11 2010
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(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 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."
SOURCE ProFibrix B.V.