BioWorld International Correspondent

ProFibrix BV raised €8.5 million (US$11.3 million) in a Series A round to fund a Phase II clinical trial of its lead product, a heat-stable, dry powder formulation of purified human fibrinogen and thrombin that is designed to overcome shortcomings associated with existing fibrin sealants.

Geneva-based Index Ventures led the round. ProFibrix, of Leiden, the Netherlands, was established in 2004 and previously had raised €475,000 in seed funding from BioPartner Start-up Ventures, a seed fund established by the Dutch Ministry of Economic Affairs, and Nottingham, UK-based Quadrant Drug Delivery Ltd., now part of Chippenham, UK-based Vectura Group plc. Quadrant also had licensed its dry powder technology - originally developed for pulmonary drug delivery - to ProFibrix, which is using it to develop a formulation of fibrinogen and thrombin that can be administered without any need for reformulation.

Thrombin catalyzes the conversion of fibrinogen to fibrin, the basic structural component of a blood clot. Existing products, ProFibrix CEO Jaap Koopman told BioWorld International, typically are sold in freeze-dried form and have to be reconstituted as a liquid before administration, a process that can take up to 30 minutes. When heavy bleeding occurs unexpectedly, such as during surgery, for example, the lag can be critical.

Other firms are developing stand-alone thrombin products that react with whatever fibrinogen is available. New York-based Omrix Biopharmaceuticals, Inc., and Zymogenetics, Inc., of Seattle, have BLAs on file at the FDA, while Bristol, Tenn.-based King Pharmaceuticals Inc. markets a bovine version of the protein.

Quadrant's formulation technology involves the use of the sugar trehalose, which Koopman said appears to maintain fibrinogen in an active conformation. The particle-based suspension dissolves on application to the site of bleeding and it reacts with the thrombin present immediately. Because of its ease of use, ProFibrix aims to extend the use of its fibrin sealant - called Fibrocaps - beyond surgical and trauma settings to the ambulance or to battlefield situations. It may even have potential for home use.

The company will spend the rest of this year and much of next year preparing for a Phase II study. "That will start at the end of 2008," Koopman said. It first has to establish a manufacturing process that can be transferred to a GMP facility and to complete animal toxicology studies. However, because of widespread clinical experience with fibrin sealants, the development risk associated with the program has been minimized, he said. "The clinical trajectory is known. The endpoints are known."

Koopman previously was scientific director at Pharming, also of Leiden. ProFibrix co-founder Herman de Boer is a co-founder of Pharming, which has a recombinant fibrinogen development program under way, but there is no formal relationship between the two firms.

The third member of ProFibrix's founding team is Susan Lord, of the University of North Carolina, Chapel Hill, N.C. The company also named Bram Bout, formerly vice president of protein production at Crucell NV, also of Leiden, as its new chief technology officer.