Baxter Healthcare Corporation announced the start of a Phase I, multicenter clinical trial for its investigational, recombinant von Willebrand factor (rVWF). The therapy is being initially tested among patients with type III von Willebrand disease (VWD), the most severe type. Type III VWD patients have only 5%-10% of the normal VWF levels in their blood, experiencing such symptoms as nosebleeds, and joint and muscle bleeds. Women can experience menorrhagia (heavy and prolonged menstrual bleeding) and postpartum bleeding. The controlled, randomized, single-blind prospective trial is underway in Europe and North America.
“All current therapies for von Willebrand disease are derived from human plasma. A plasma- and albumin-free recombinant therapy would eliminate the potential risk of transmitting blood-borne pathogens since no blood components are added at any stage of manufacturing,” said Hartmut Ehrlich, MD, vice president of global research and development for Baxter’s BioScience business. “Achieving this milestone is significant in supporting our commitment to improve care for the bleeding disorder community.”
Source: Baxter press release dated December 4, 2008