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 products
for hemostasis, today announced that it has initiated a prospective,
multi-center Phase II study with its lead product Fibrocaps at up to
20 sites, including major U.S. and Dutch academic medical centers.

Jaap Koopman, CEO of ProFibrix said: "The start of this large
Phase II study in multiple surgical indications is a major milestone
in the rapid development of our lead product Fibrocaps. If, as we
expect, this study confirms the positive results of our first Phase
II trial, we anticipate initiating a pivotal Phase III trial in early
2012, which puts us on track for a BLA filing early 2013."

About Fibrocaps

Fibrocaps is based on a mixture of two essential blood clotting
proteins, fibrinogen and thrombin, and is a unique dry powder topical
fibrin sealant being developed to stop bleeding during or after
surgery. Fibrocaps is clearly differentiated from existing liquid
tissue sealants and hemostats: it is ready for immediate use, and is
stable at room temperature.

About the Study

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

To allow ProFibrix to conduct the Fibrocaps Phase II clinical
trial 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 open
and ProFibrix has started enrolling patients at the participating
centers in the U.S. and EU. For more details on the study, please go
to http://www.clinicaltrials.gov.

About ProFibrix

ProFibrix (http://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.

ots Originaltext: ProFibrix BV
Im 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