ProFibrix, a developer of hemostasis and regenerative medicine products, has reported Fibrocaps positive Phase II study results.
Fabrics is a mixture of two essential blood clotting proteins, fibrin and thrombi, and is a unique dry powder topical fibrin sealant being developed to stop bleeding during or after surgery.
The controlled, multimeter, prospective, randomised, single-blind US study, enrolling 70 patients with mild to moderate surgical bleeding, was designed to study the Fibrocaps ‘ mean time to hemostasis (TTH) after spinal, peripheral vascular and general surgery.
The study met primary efficacy endpoint with a pooled intent-to-treat analysis of the mean TTH of Fibrocaps versus active control.
The study also met secondary endpoints of incidence of hemostasis at 10, 5 and 3 min with p-values of 0.003, 0.001 and <0.001, respectively.
ProFibrix CEO Jan Ohrstrom said they plan to start a pivotal Phase III trial in H1 2012, and target a BLA filing in 2013.
"We believe that after launch Fibrocaps should be able to command a large share of the US$ 1 billion topical hemostat market," Ohrstrom said.