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Baxter to commence new phase III trial of Kiovig
Baxter has announced plans to conduct a new phase III clinical study of its Alzheimer's disease treatment Kiovig.
The second of two confirmatory trials of the drug will commence in the first quarter of 2012, following the successful conclusion of a futility analysis in its first phase III study.
A global multicentre clinical trial that will enrol around 400 patients, the study will be identical in design to the first and will evaluate Kiovig's safety and efficacy compared to standard of care over an 18-month period.
Kiovig is known as Gammagard Liquid Ten Percent in the US and Canada and is currently indicated as a replacement therapy for primary humeral immunodeficiency.
Dr Ludwig Hantson, president of Baxter's bioscience business, said: "If successful, Baxter's phase III trials will support a regulatory filing for use of immunoglobulin therapy in the treatment of Alzheimer's disease."
Last month, the company announced that it will be committing to new research in the field of biosimilars via a collaboration with Momenta Pharmaceuticals.
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