ProFibrix Phase II with FibrocapsTM Meets Primary Endpoint – On Track for Phase III in 2012
LEIDEN, The Netherlands & SEATTLE - 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.”
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 Study
The Phase II clinical trial of Fibrocaps (FC-002 NL) was a prospective, randomized (2:1), single-blind, controlled study in 56 subjects undergoing liver resection surgery. The Dutch study was conducted at 5 sites, which included major medical centers in the Netherlands. Fibrocaps was considered to have a very good safety profile, with no adverse events attributed to Fibrocaps, which is consistent with the previously conducted Phase II study. The primary efficacy endpoint of the study was an intent-to-treat analysis of the mean TTH of Fibrocaps versus active control. The TTH means were 2.2 min for Fibrocaps (n=39) and 4.4 min for control (n=17) (p=0.004).
ProFibrix conducted the Fibrocaps Phase II study in the Netherlands under a Clinical Trial Application (CTA) as required by the Dutch Central Committee on Research involving Human Subjects (CCMO). For more details on the study, please go to http://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.