Date: 2014-10-28
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the 100th Clinical Congress of the American College of Surgeons in San Francisco
Company: ProFibrix (The Netherlands)
Product: Fibrocaps™/Raplixa™
Action
mechanism: Fibrocaps™ is based on a mixture of two essential blood clotting proteins, fibrinogen and thrombin, and is a unique dry powder topical fibrin sealant being developed to stop bleeding during or after surgery.
Disease: hemostasis
Therapeutic area: Hemostasis
Country: Europe, USA
Trial
details: FINISH-3 is a prospective, randomized (2:1), single-blind, controlled, pivotal Phase III trial of Fibrocaps vs. active control in 672 subjects undergoing spinal (n=168), liver (n=168), vascular (n=168) and soft tissue surgery (n=168). The study will be conducted at 65 sites across Europe and the U.S. Estimated completion will be in second quarter 2013. (NCT01527357)
Latest
news: * On October 28, 2014, The Medicines Company announced the presentation of the results of the pivotal Phase III clinical trial of the investigational hemostatic agent Raplixa™ (fibrin sealant), formerly known as Fibrocaps, at the 100th Clinical Congress of the American College of Surgeons in San Francisco, CA. As previously reported, the Phase III trial, FINISH-3, which studied a total of 719 patients, met all primary and secondary hemostasis efficacy endpoints in four distinct surgical indications of spinal surgery, hepatic resection, vascular surgery and soft tissue dissection. Patients were treated (Raplixa™: 480; gelatin sponge: 239) while undergoing spinal (n=183), vascular (n=175), hepatic (n=180), or soft tissue (n=181) procedures. Raplixa™ was applied by spray device in 53 percent of all procedures (94 percent of hepatic and soft tissue procedures).Raplixa™ significantly reduced TTH compared to gelatin sponge; estimated hazard ratios were 3.3, 2.1, 2.3, and 3.4 for the four surgical indications, respectively (each p<0.001; primary endpoint).Raplixa™ significantly reduced median TTH for each indication (p<0.0001), and was superior for secondary efficacy endpoints of restricted mean TTH (p<0.0001) and probability of hemostasis at 3 (p<0.0001) and 5 (p≤0.002) minutes. Adverse event incidences were generally similar between treatment arms. Non-neutralizing, anti-thrombin antibodies developed in 2 percent of Raplixa™ -treated and 3 percent of gelatin sponge-treated patients. * On August 5, 2013, The Medicines Company has 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 hemostasis during surgery. The Phase III trial, FINISH-3, which studied a total of 719 patients, met all primary and secondary hemostasis 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 hemostat 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. As previously announced, The Medicines Company entered into an agreement with ProFibrix in June 2013 to purchase all of the equity of ProFibrix B.V. subject to its review of the results of the FINISH-3 trial. Based on its review, The Medicines Company purchased all of the outstanding equity of ProFibrix for $90 million at the closing held today and agreed to pay ProFibrix equityholders up to an additional $140 million upon the achievement of agreed-upon U.S. and European regulatory approvals and sales milestones.
* On February 13, 2013, ProFibrix has announced that the Data Monitoring Committee (DMC) of the FINISH-3 trial of Fibrocaps unanimously recommended the study to continue as designed. The DMC is an independent expert panel overseeing patient safety of this pivotal trial in spine, liver, vascular and soft tissue surgery. At its final meeting, the DMC reviewed data from the first 403 subjects enrolled in the trial, and found no safety concerns.
To date, less than 9 months after the first subject was enrolled, over 85% of the 672 subjects necessary to complete enrolment have already been recruited into the study. Two of the four surgical indications, spinal and soft tissue surgery, completed enrolling. Full enrolment is expected to be completed in April 2013 and final results from the study are anticipated in June 2013.
* On November 8, 2012, ProFibrix, a leader in the development of innovative bioactive products to stop bleeding (hemostasis), has announced that the company has enrolled already more than half of the patients in its pivotal Phase III clinical trial with Fibrocaps (FINISH-3). In addition, it successfully concluded a meeting of the Data Monitoring Committee (DMC), an independent expert panel overseeing patient safety and treatment efficacy. The main objectives of the study are to demonstrate superior efficacy of Fibrocaps vs. gelatin sponge within each of four surgical indications, and to confirm the overall safety results from the Phase II Fibrocaps trials. Fibrocaps is slated to be launched in 2014.
