ProFibrix Completes Patient Enrolment in Pivotal Phase III With Fibrocaps and Reports Positive Feedback From Surgical Community
Published: Apr 04, 2013
LEIDEN, The Netherlands & SEATTLE--(BUSINESS WIRE)--ProFibrix B.V., a leader in the development of innovative bioactive products to stop bleeding (hemostasis), today announced that the company has completed enrolment of its pivotal Phase III clinical trial with Fibrocaps (FINISH-3) on schedule. FINISH-3 is a multicenter, randomized, single-blind, controlled Phase III trial of Fibrocaps in surgical patients with mild to moderate surgical bleeding. Participating surgeons enrolled a total of 718 patients in only 10 months. The main objectives of the study are to demonstrate superior efficacy of Fibrocaps vs. gelatin sponge within four surgical indications, and to confirm the overall safety results from the Phase II Fibrocaps trials. Final study results are expected to be announced in the summer of 2013.