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Baxter begins phase III trial of von Willebrand disease therapy
Baxter has commenced a phase III clinical trial of BAX 111, a new therapy for patients with von Willebrand disease.
The investigational treatment for the inherited bleeding disorder is to be assessed in terms of safety, efficacy and pharmacokinetics, with regard to its success in preventing bleeding episodes and improving quality of life.
A minimum of 36 patients will be enrolled for the study internationally, with researchers to evaluate the drug's effect on the physical, emotional and social functioning of patients.
BAX 111 is the first recombinant von Willebrand product in clinical development and will aid in the treatment of a condition that frequently goes undiagnosed, due to its mild symptoms.
Dr Bruce Ewenstein, vice-president of clinical affairs in Baxter's bioscience business, said: "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."
Earlier this month, the company submitted an application for European regulatory approval of HyQ, an investigational primary immunodeficiency therapy.
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