BLA filing for fibrinogen- and thrombin-based product is projected for 2013.
Netherlands-based ProFibrix raised $22 million through a series B follow-on financing round and the receipt of government credit to fund progression of its lead Fibrocaps product into late-stage clinical development and support additional pipeline products.
The firm is exploiting its expertise in fibrinogen technology to develop and market products for the hemostasis and regenerative medicine markets. Lead clinical-stage product, Fibrocaps, is based on a mixture of two essential blood-clotting proteins, fibrinogen and thrombin, formulated as a dry powder topical fibrin sealant to stop bleeding during or after surgery. In March ProFibrix started a second Phase II trial evaluating Fibrocaps at sites in Europe and the U.S. The study will evaluate the use of Fibrocaps in about 130 patients undergoing a range of surgical procedures including peripheral vascular surgery, spinal surgery, liver resection surgery, and soft tissue dissection. The primary efficacy endpoint of the study is the mean time to hemostasis following application of Fibrocaps versus control.
On announcing start of the Phase II study last month, Jaap Koopman, CEO of ProFibrix, said, “If, as we expect, this study confirms the positive results of our first Phase II trial, we anticipate initiating a pivotal Phase III trial in early 2012, which puts us on track for a BLA filing early 2013.”
ProFibrix is separately working to establish a commercially feasible recombinant production platform for human fibrinogen. The firm claims it has already established the cost-effective production of recombinant human fibrinogen in PER.C6® cells and is working with a cGMP manufacturer to expand the production of recombinant fibrinogen to industrial volumes.
ProFibrix claims the recombinant fibrinogen platform allows the development of a range of fibrinogen-based products for the hemostasis and tissue-repair market. Initial product development programs may include a systemic therapy for patients with inadequate levels of circulating functional fibrinogen.
