Fibrocaps Phase III success in Phase III trial for Haemostasis

The Medicines Company announced the results of the pivotal Phase III clinical trial of ProFibrix's lead biologic, Fibrocaps, a dry powder topical formulation of fibrinogen and thrombin being developed to aid in haemostasis during surgery. The Phase III trial, FINISH-3, which studied a total of 719 patients, met all primary and secondary haemostasis efficacy endpoints in four distinct surgical indications of spinal surgery, hepatic resection, soft tissue dissection and vascular surgery. The Medicines Company expects the results of FINISH-3, which was conducted at 65 sites across the U.S. and Western Europe, to support a biologics license application (BLA) with the FDA and a marketing authorisation application (MAA) with the European Medicines Agency. ProFibrix has also developed a complementary dry powder spray delivery device to assist surgeons in the accurate application of Fibrocaps. Recently the ProFibrix quality management system for the design, development and control of manufacture of sterile biological haemostat delivery systems and their accessories was granted ISO 14385: 2003 certification. Applications for a European CE mark and for an FDA 510k review for the device are underway.

The Medicines Company has now acquired ownership of ProFibrix.