LEIDEN, The Netherlands & SEATTLE--()--ProFibrix B.V., the leader in next generation hemostatics, today announced that the Data Monitoring Committee (DMC) of the FINISH-3 trial of Fibrocaps unanimously recommended the study to continue as designed. The DMC is an independent expert panel overseeing patient safety of this pivotal trial in spine, liver, vascular and soft tissue surgery. At its final meeting, the DMC reviewed data from the first 403 subjects enrolled in the trial, and found no safety concerns.
To date, less than 9 months after the first subject was enrolled, over 85% of the 672 subjects necessary to complete enrolment have already been recruited into the study. Two of the four surgical indications, spinal and soft tissue surgery, completed enrolling. Full enrolment is expected to be completed in April 2013 and final results from the study are anticipated in June 2013.
Jan Öhrström, Chief Executive Officer of ProFibrix said: “The positive review by the DMC bodes well for our filings with U.S. and EU authorities in the fall of 2013. Furthermore, the strong support of the investigators involved in FINISH-3 has resulted in an amazing speed of enrolment. This strengthens our belief that Fibrocaps has the hallmarks to capture a significant part of the fast growing USD 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 for the treatment of mild to moderate bleeding in 672 subjects undergoing spinal, liver, vascular and soft tissue surgery (n=168 in each indication), conducted at 65 sites across Europe and the U.S.
For more details on the study, please click here.
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.