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news.Recombinant von Willebrand factor (rVWF) may be safe and well tolerated in patients with type 3 and severe type 1 von Willebrand disease, according to interim data from a Phase 1 multicenter, international clinical study by Baxter International.
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Safety, tolerability and pharmacokinetics of rVWF combined with rFVIII at a fixed ratio were investigated in the Phase 1 multicenter, international clinical study in 32 patients with type 3 and severe type 1 von Willebrand disease.
The interim data from 22 patients in the 32-patient study also suggest rVWF has a pharmacokinetic profile that is comparable to plasma-derived von Willebrand factor (pdVWF), the current standard for treatment for patients with the disease.
Baxter‘s investigational rVWF concentrate was developed using a plasma- and albumin-free manufacturing method, and represents the largest protein ever produced through recombinant technology.
The European Commission granted orphan designation for Baxter’s rVWF in November 2010.
Baxter Clinical Affairs vice president Bruce Ewenstein said providing patients and physicians with a plasma- and albumin-free, recombinant treatment option for a condition that is as challenging to treat as von Willebrand disease is an important focus for Baxter’s clinical research and development efforts.