Inspiration Biopharmaceuticals Highlights Positive Data on its Recombinant Factor IX for People with Hemophilia B Who Have Undergone Major Surgical Procedures
ROME, Feb. 22, 2012 /PRNewswire/ — Inspiration Biopharmaceuticals, Inc. (Inspiration) today announced clinical results for the Company’s lead product candidate, an intravenous recombinant factor IX (FIX) product being investigated for the treatment and prevention of bleeding in individuals with hemophilia B. The data demonstrated that Inspiration’s FIX product provided effective surgical hemostasis in people with hemophilia B undergoing major surgical procedures. The data were highlighted in a poster presentation at the 5th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD) in Rome, Italy.
In a poster titled, “Use of IB1001, a new investigational recombinant factor IX, in patients with hemophilia B undergoing major surgical procedures”, the newly reported data showed that a group of subjects who underwent major surgical procedures had effective control of bleeding with IB1001. Estimated intra-operative blood loss was rated as expected or less than expected in all subjects, and IB1001 was well-tolerated with few adverse events. Fourteen subjects, ages 12 and above, were enrolled in the study. Twelve underwent orthopedic procedures, with one inguinal repair and one hysterectomy. Subjects received either bolus or continuous infusion of IB1001 to support surgery, and for a minimum of three days post procedure. Hemostasis was evaluated at 12 hours and 24 hours post procedure. Post-surgical hemostasis was considered adequate or superior at both evaluation points in all subjects.
Howard Levy, M.D., Ph.D., Senior Vice President and Chief Medical Officer of Inspiration commented, “We are very encouraged by the results of this surgery study. Surgery is especially complicated for individuals with hemophilia due to the potential for significant blood loss.”
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