During the World Federation of Hemophilia (WFH) 2014 World Congress, May 11-15, 2014, in Melbourne, Australia, Baxter presented updates on the following bleeding disorders therapies that are in its development pipeline:
BAX 855
BAX 855 is an extended half-life investigational recombinant factor VIII (rFVIII) treatment for hemophilia A. It is based on the full-length ADVATE (Baxter’s recombinant factor VIII product) molecule, and is modified with PEGylation technology to extend its duration of activity in the body. Data from clinical studies of its efficacy and safety demonstrate the investigational treatment's structural and functional integrity.
ADVATE
Multiple studies were presented on ADVATE, including a meta-analysis of ADVATE-PASS (Post-Authorization Safety Studies), an open-label study, documenting the real-world clinical experience with this therapy. Conducted in multiple countries between July 2003 and January 2014, the results presented at WFH are the first to demonstrate the safety and efficacy of routine use of rFVIII concentrate in patients with hemophilia A and a low titer inhibitor or inhibitor history.
OBI-1
Several presentations focused on OBI-1, an investigational recombinant porcine sequence FVIII therapy. The investigational treatment has completed a phase 2/3 study and is now under regulatory review in the US for the treatment of acquired hemophilia A. The data presented offered insights into the safety, efficacy and immunogenicity of OBI-1 in patients with acquired hemophilia A.
BAX 111
Data highlighted the scientific concepts behind BAX 111, the company’s recombinant von Willebrand factor product to treat bleeding episodes in patients with von Willebrand disease (VWD). It is the first recombinant factor replacement therapy for VWD to reach this stage of clinical development.
“The data presented at WFH demonstrate the breadth of our pipeline and Baxter’s dedication to delivering innovative treatment solutions that may help lessen the burden on patients around the world,” said Bruce Ewenstein, MD, PhD, vice president of clinical affairs, Baxter BioScience. “We are focused on driving scientific advancements that can make meaningful improvements in patient care across a range of bleeding and other coagulation disorders while contributing to the scientific understanding of these diseases.”
Source: Baxter press release dated May 12, 2014
