VIRTUE clinical trial opens to primary immunodeficiency patients across the U.S.

KING OF PRUSSIA, PA-September 12, 2006. ZLB Behring has announced the launch of the VIRTUE Trial, a Phase IV clinical trial of the study medication Vivaglobin (Immune Globulin Subcutaneous, Human), the first and only U.S. Food and Drug Administration-approved subcutaneous immunoglobulin (Ig) treatment for patients with primary immunodeficiency (PI). VIRTUE [Vivaglobin Investigator Research Trial on Use and Experience], will evaluate patient satisfaction and annual rate of serious bacterial infection using Vivaglobin subcutaneous administration for one year after conversion from intravenous immunoglobulin therapy.

VIRTUE will enroll 100 PI patients at 50 sites across the country, making it the largest-ever trial of subcutaneous (i.e., under the skin) immunoglobulin therapy in the United States. Patients enrolled in the study will self-administer the study medication for one year. During the trial period, patients will be asked to assess overall health-related quality of life, comparing experience receiving the study medication and their previous intravenous treatment experience. Additionally, VIRTUE will identify which patients are more inclined to use SC treatment because of the improvement in their quality of life.

"Being able to self-administer Vivaglobin at home will add a great deal of flexibility and convenience to the lives of many patients who wont have to go to the doctors office any longer to receive their therapy," said Dr. Melvin Berger, Professor of Pediatrics and Pathology at Case Western Reserve University and one of the lead researchers for the trial. "Some patients suffering from PI may not be able to use IVIg because of poor venous access, intolerability or severe adverse effects. Other patients may be too busy or cannot afford to take the time off from work or school to get to an infusion center every three or four weeks. SC, or subcutaneous treatment, may benefit these patients."

The study medication, Vivaglobin,

Contact: Sheila Burke
ZLB Behring

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