LEIDEN, The Netherlands & SEATTLE--()--ProFibrix B.V., a leader in the development of innovative bioactive products to stop bleeding (hemostasis), today announced that the company has enrolled already more than half of the patients in its pivotal Phase III clinical trial with Fibrocaps (FINISH-3). In addition, it successfully concluded a meeting of the Data Monitoring Committee (DMC), an independent expert panel overseeing patient safety and treatment efficacy.
FINISH-3 is a multicenter, randomized, single-blind, controlled Phase III trial of Fibrocaps in a total of 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 of four surgical indications, and to confirm the overall safety results from the Phase II Fibrocaps trials. Fibrocaps is slated to be launched in 2014.
Jan Ohrstrom, Chief Executive Officer of ProFibrix said: “The pace of enrolment in our Phase III study is proof of the commitment and strong endorsement of our principal investigators. We are also very pleased with passing the DMC review. We remain firmly 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 topical hemostat market, which is currently at US$ 1 billion and growing.”
Fibrocaps is a mixture of two essential blood clotting proteins, fibrinogen and thrombin, formulated as a unique dry powder topical fibrin sealant, which is being developed to stop bleeding during or after surgery. Fibrocaps is clearly differentiated from existing liquid fibrin 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 will be in second quarter 2013.
For more details on the study, please go to http://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.