ProFibrix Initiates Phase II With Lead Hemostasis Product Fibrocaps(TM) in US and Europe
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.
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.”
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
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
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
patients at the participating centers in the U.S. and EU. For more details on
the study, please go to http://www.clinicaltrials.gov.
ProFibrix (http://www.profibrix.com) was founded in 2004 and is
headquartered in Leiden,
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.
SOURCE ProFibrix BV