ProFibrix' US multicentre, Phase II trial (FC-002 US) with Fibrocaps in spinal, peripheral vascular and general surgery, has resulted in a highly statistically significant reduction in mean time to haemostasis (TTH) and incidence of haemostasis at three, five and ten minutes, as compared with active control.
A total of 70 patients were enrolled in FC-002 US, the company's US, prospective, randomised, single-blind, controlled, multicentre Phase II study, with lead product Fibrocaps for mild-to-moderate surgical bleeding. The study results confirm the efficacy and safety results recently obtained from a Dutch Phase II study in hepatic resection.
FC-002 US was a prospective, randomised (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 eight sites across the US. Fibrocaps was considered to have a very good safety profile, with no adverse events attributed to Fibrocaps, which is consistent with the previously conducted Dutch 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 haemostasis at ten, five and thee minutes were all statistically significant, with p-values of 0.003, 0.001 and <0.001, respectively.
Fibrocaps is a mixture of two essential blood clotting proteins, fibrinogen and thrombin, and is a dry-powder topical fibrin sealant being developed to stop bleeding during or after surgery.