ProFibrix Initiates Phase II Clinical Trial of its Lead Topical Hemostat Product Fibrocaps(TM)



    SEATTLE, WA and LEIDEN, The Netherlands, June 18 /CNW/ - ProFibrix B.V.
today announced the start of the company's Phase II clinical trial for
Fibrocaps(TM), the company's lead topical Hemostat product, with the
successful treatment of the first patients for mild to moderate bleeding
during liver surgery. ProFibrix expects to complete the study before the end
of 2009.
    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 expects to submit an Investigational New Drug Application (IND)
for Fibrocaps to the U.S. Food and Drug Administration in the first half of
2010, and conduct a combined phase II/III pivotal study in various surgical
indications.
    Jaap Koopman, PhD, Chief Executive Officer, said: "The successful
treatment of the first patients with our lead product Fibrocaps is an
important milestone for the company. With focus and dedication we have made
enormous progress over the past two years, and we are on track to bring
Fibrocaps to the point of market approval."

    About ProFibrix

    ProFibrix was founded in 2004 and is headquartered in Leiden, The
Netherlands, with a subsidiary in Seattle, WA. 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.





For further information:

For further information: 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-(0)2069105404, E-mail: j.ohrstrom@profibrix.com

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