Leiden, The Netherlands & Seattle – ProFibrix B.V., a leader in the development of innovative bioactive products to stop bleeding (hemostasis), today announced the start of its pivotal Phase III clinical trial with Fibrocaps (FINISH-3) in spine, liver, vascular and soft tissue surgery.
FINISH-3 is a multicenter, randomized, single-blind, controlled Phase III trial of Fibrocaps in 672 surgical patients with mild to moderate surgical bleeding. The main objectives of the study are to demonstrate superior efficacy of Fibrocaps vs. gelatin sponge within each surgical indication, and to confirm the overall safety results from the Phase II Fibrocaps trials completed in 2011.
Dr. Paul Frohna, Chief Medical Officer of ProFibrix said:
“We are very pleased to announce the randomization and treatment of the first patients in the international FINISH-3 trial less than 4 months after completing our End-of-Phase II meeting with the U.S. FDA. Based on the excellent Phase II study results, the investigators are very eager to enroll their patients into our study and we remain on track for regulatory filings in the U.S. and EU in 2013. Based on the product’s unique properties, and the overwhelmingly positive feedback we are receiving from the surgical community, we believe Fibrocaps should be able to capture a substantial share of the US$ 1 billion topical hemostat market.”
Fibrocaps is 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 FINISH-3 trial
FINISH-3 is a prospective, randomized (2:1), single-blind, controlled, pivotal Phase III trial of Fibrocaps vs. active control in 672 subjects undergoing spinal (n=168), liver (n=168), vascular (n=168) and soft tissue surgery (n=168). The study will be conducted at 65 sites across Europe and the U.S. Estimated completion date is May 2013. For more details on the study, please go to www.clinicaltrials.gov.
ProFibrix (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 bring to 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.