LEIDEN, The Netherlands & SEATTLE —(BUSINESS WIRE)— ProFibrix B.V., a leader in the development of innovative products for hemostasis, today announced that it has completed patient enrollment in its two (U.S. and Dutch) prospective, randomized, controlled, multi-center Phase II studies with lead product Fibrocaps in surgical hemostasis.
Jan Ohrstrom, CEO of ProFibrix said:
“We’re very pleased with the rapid completion of this Phase II program in multiple surgical indications. With a follow-up of approximately one month, we look forward to reporting on the outcome of the trials before the end of 2011, and initiate a pivotal Phase III trial in H1 2012, which puts us on track for a BLA filing in 2013.”
Fibrocaps is based on 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 Studies
These Phase II clinical trials of Fibrocaps (FC-002 US and FC-002 NL) build on the success of ProFibrix’s first Phase II study at a number of centers in the Netherlands, which demonstrated a compelling safety and efficacy profile for Fibrocaps. The current Phase II trials are prospective, randomized, single-blind, controlled studies. The U.S. study was conducted at 11 sites and the Dutch study was conducted at 5 sites, which included major academic and leading private medical centers in the U.S. and the Netherlands. Apart from measuring overall safety, the primary efficacy endpoint of the study is the mean time to hemostasis (TTH) of Fibrocaps versus control. A total of 124 patients have been randomized across three different surgical indications: peripheral vascular surgery, spinal surgery, and liver resection surgery. The study has a 28-day follow-up and results are expected to be reported before the end of 2011.
ProFibrix conducted the Fibrocaps Phase II clinical trial in the U.S. under an Investigational New Drug (IND) application as required by the U.S. Food and Drug Administration. The Netherlands study was conducted under a Clinical Trial Application (CTA) as required by the Dutch Central Committee on Research involving Human Subjects (CCMO). For more details on the studies, please go to 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.