LEIDEN, The Netherlands and SEATTLE, March 8, 2011 /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."
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.
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.
SOURCE ProFibrix BV