Company remains on track for 2013 filings in US and Europe
LEIDEN, The Netherlands & SEATTLE – ProFibrix B.V., a leader in innovative bioactive products to stop bleeding (hemostasis), today announced that the company has completed enrolment of its pivotal Phase III clinical trial with Fibrocaps (FINISH-3) on schedule.
FINISH-3 is a multicenter, randomized, single-blind, controlled Phase III trial of Fibrocaps in surgical patients with mild to moderate surgical bleeding. Participating surgeons enrolled a total of 718 patients in only 10 months. The main objectives of the study are to demonstrate superior efficacy of Fibrocaps vs. gelatin sponge within four surgical indications, and to confirm the overall safety results from the Phase II Fibrocaps trials. Final study results are expected to be announced in the summer of 2013.
Jan Öhrström, Chief Executive Officer of ProFibrix said:
“As enrolment neared completion, we found that participating surgeons repeatedly asked us to allow them to include even more patients, because they find Fibrocaps easy to use and working well in their specific surgical procedures. Based on the very positive response from the surgical community throughout our Phase III trial, we are confident that Fibrocaps will be able to rapidly capture a substantial share of the topical hemostat market, which is currently at US$ 1 billion and growing. With our regulatory filings in the U.S. and EU on track for 2013, we expect to launch Fibrocaps in 2014.”
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 718 subjects undergoing spinal (n=183), liver (n=180), vascular (n=174) and soft tissue surgery (n=181). The study was conducted at 65 sites across Europe and the U.S.
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.
Jan Öhrström, MD, CEO
+31 63 1774 620