LEIDEN, The Netherlands & SEATTLE – ProFibrix B.V., a leader in the development of innovative products for hemostasis, today announced that its U.S. multicenter Phase II clinical trial with Fibrocaps in spinal, peripheral vascular and general surgery resulted in a highly statistically significant reduction in mean time to hemostasis (TTH) and incidence of hemostasis at 3, 5 and 10 minutes, as compared to active control.
A total of 70 patients were enrolled in the company’s U.S., prospective, randomized, single-blind, controlled, multicenter Phase II study with lead product Fibrocaps for mild to moderate surgical bleeding. The US study results confirm the efficacy and safety results recently reported from the Dutch Phase II study in hepatic resection. Both studies demonstrate that Fibrocaps has a very good safety profile comparable to active control, along with rapid hemostatic activity across multiple surgical indications.
Dr. Neil Singla, one of the Principal Investigators of the US Phase II study, said:
“The combined ease of use and efficacy of Fibrocaps in spinal and vascular surgery constitute a great leap forward in hemostasis in these surgical settings. These surgeries require optimal precision and thanks to the rapid time to hemostasis of Fibrocaps we can quickly and safely obtain a clear field of vision during these interventions.”
Jan Öhrström, CEO of ProFibrix said:
“We are delighted that the positive results of the US Phase II study confirm the results from our European study reported in November 2011. In fact, the results of the two Phase II clinical trials have de-risked the Fibrocaps program substantially. We plan to initiate a pivotal Phase III trial in H1 2012, and target a BLA filing in 2013. Based on its strong and competitive properties, we believe that after launch Fibrocaps should be able to command a large share of the US$ 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 Study
The Phase II clinical trial of Fibrocaps (FC-002 US) was a prospective, randomized (2:1), single-blind, controlled study in 70 subjects undergoing spinal (n=37), peripheral vascular (n=30) and general surgery (n=3). The study was conducted at 8 sites across the U.S. 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 a pooled intent-to-treat analysis of the mean TTH of Fibrocaps versus active control. The TTH means ± SD were 1.9 ± 1.3 min for Fibrocaps (n=47) and 4.8 ± 3.1 min for control (n=23) (p<0.001). The secondary endpoints of incidence of hemostasis at 10, 5 and 3 min were all statistically significant, with p-values of 0.003, 0.001 and <0.001, respectively.
ProFibrix conducted the Fibrocaps Phase II study in the U.S. under an open IND with the FDA. 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.