Fibrocaps™
The lead product from ProFibrix, Fibrocaps (proposed name), is currently being studied for treatment of bleeding during surgery and after trauma injury.
The Fibrocaps Phase 2 clinical program was conducted in both the US and the Netherlands (NL). A total of 56 patients were enrolled in the company’s NL prospective, randomized, controlled, multi-center study with Fibrocaps as a hemostatic agent for mild to moderate surgical bleeding. The study results show that Fibrocaps had a very good safety profile along with rapid hemostatic activity that succeeds in significantly reducing mean time to hemostasis, the primary end point. A total of 70 patients undergoing spinal, peripheral vascular, and general surgery were studied in the US clinical trial. Results showed a very good safety profile, with no adverse events attributed to Fibrocaps, consistent with the study in the NL. The primary efficacy endpoint of the US 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 2 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.
