Baxter commences BAX 111 Phase III trial in von Willebrand disease

Baxter International Inc. today announced initiation of a Phase III clinical trial to evaluate the safety and effectiveness of BAX 111, Baxter's investigational recombinant von Willebrand factor (rVWF), for the treatment and prevention of bleeding episodes in patients with von Willebrand disease. This condition is the most common type of inherited bleeding disorder, affecting both men and women, the majority of whom are undiagnosed due to mild symptoms. BAX 111 is the first recombinant von Willebrand product in clinical development.

"Currently available treatments that are effective for von Willebrand disease are produced from human plasma. Baxter's investigational rVWF does not contain blood-based additives," said Bruce Ewenstein, M.D., Ph.D., vice president, Clinical Affairs in Baxter's BioScience business. "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."

The Phase III multicenter, open-label clinical trial is enrolling patients with severe von Willebrand disease and will assess the safety, effectiveness and pharmacokinetics of BAX 111 for the prevention and treatment of bleeding episodes. The primary endpoint is the number of patients experiencing treatment success for treated bleeding episodes. The trial will also assess changes in health-related quality of life (HRQoL) associated with the treatment. Standardized measures will be used to assess the overall impact of six months of recombinant treatment on the physical, emotional and social functioning of patients with von Willebrand disease.