LEIDEN, The Netherlands & SEATTLE--(BUSINESS WIRE)-- ProFibrix B.V., a leader in the development of innovative products for hemostasis, today announced that its multicenter Phase II clinical trial with Fibrocaps in liver resection surgery resulted in a highly statistically significant 50% reduction in mean time to hemostasis (TTH) compared to active control.
A total of 56 patients were enrolled in the company’s Dutch prospective, randomized, controlled, multi-center Phase II study with lead product Fibrocaps for mild to moderate surgical bleeding. The study results show that Fibrocaps has a very good safety profile along with rapid hemostatic activity that succeeds in significantly reducing mean time to hemostasis, the primary end point of the Phase II trial.
Professor dr. R.J. Porte from the University Medical Center Groningen, the Lead Investigator of the study, said: “We’re very pleased with the excellent performance of Fibrocaps in this Phase II study. I have no doubt that the substantial reduction in mean time to hemostasis we report for Fibrocaps is clinically very meaningful, and demonstrates the strength of this unique dry powder formulation of fibrinogen and thrombin.”
Jan Öhrström, CEO of ProFibrix said: “Our clinical data constitute the strongest result ever reported for fibrin sealants in a Phase II study in this indication. These positive results ensure that we remain on track to initiate a pivotal Phase III trial in H1 2012, and target a BLA filing in 2013. In the coming months we expect to report on the results of the Phase II trial we are running in parallel in the U.S. Altogether we believe that the positive outcome of the European and U.S studies should allow us to generate strong support from investors as we continue developing Fibrocaps and its line extensions.”