“The combined ease of use and efficacy of Fibrocaps in spinal and vascular surgery constitute a great leap forward in haemostasis in these surgical settings.”
ProFibrix B.V., a leader in the development of innovative products for haemostasis, has 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 haemostasis (TTH) and incidence of haemostasis at 3, 5 and 10 minutes, as compared to active control.
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. Profibrix claims that Fibrocaps is clearly differentiated from existing liquid tissue sealants and haemostats: it is ready for immediate use, and is stable at room temperature.
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 haemostatic 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 haemostasis in these surgical settings. These surgeries require optimal precision and thanks to the rapid time to haemostasis 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.”