Baxter's Recombinant VWF Product Starting Phase 3 Clinical Trial
In October, Baxter International, Inc., announced the initiation of a Phase 3 clinical trial to evaluate the safety and effectiveness of BAX 111, the company’s investigational recombinant von Willebrand factor (rVWF) therapy. rVWF is being developed for the treatment and prevention of bleeding episodes in patients with von Willebrand disease (VWD). VWD is the most common inherited bleeding disorder, affecting women and men equally. It is caused by defective or deficient VWF. BAX 111 is the first recombinant von Willebrand product in clinical development.
The multicenter open-label clinical trial, currently enrolling patients with severe VWD, will assess the safety, effectiveness and pharmacokinetics of BAX 111 for the prevention and treatment of bleeding episodes. The trial is also designed to assess changes in health-related quality of life associated with the therapy. According to the Baxter press release, the study will employ “standardized measures” to assess the overall impact of six months of rVWF on the physical, emotional and social functioning of VWD patients.
“The initiation of the BAX 111 Phase III trial represents a significant step forward as the product, if proven safe and effective, may lead to an alternative treatment choice for clinicians and their patients with von Willebrand disease,” said Bruce Ewenstein, MD, PhD, vice president, Clinical Affairs in Baxter’s BioScience business.
The study will include a minimum of 36 patients in the US, Canada, Europe, Australia, Japan and India. Information about the trial, including enrollment, is available at: www.clinicaltrials.gov or by calling 1.805.372.3322.