Mental HealthProFibrix Initiates Phase II Clinical Trial Of Its Lead Topical Hemostat Product Fibrocaps(TM)
ProFibrix B.V. 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."
ProFibrix B.V.