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Octapharma Targeting the Major Risk of Hemophilia Treatment - FVIII Antibodies
Date:8/26/2009

art Kreuz, M.D. of the Hemophilia Comprehensive Care Centre at Johann Wolfgang Goethe University Hospital in Frankfurt, Germany. "Successful ITI leads to normalization of the FVIII half-life, allows fully effective on-demand replacement therapy and prophylaxis, with consequent improvement in the patient's quality of life and a marked reduction in the cost of treatment."

The Octapharma-sponsored symposium "From Humans to Humans - Introducing the First Recombinant FVIII Produced From a Human Cell Line" was chaired by Edward G.D. Tuddenham, M.D., Director of The Katharine Dormandy Haemophilia Center & Thrombosis Unit in London, and Johannes Oldenburg, M.D., Ph.D., Chairman and Director of the Institute of Experimental Haematology and Transfusion Medicine in Bonn, Germany.

"Twenty years after the start of clinical trials with rFVIII concentrates expressed by hamster cells, a new rFVIII compound has recently entered clinical studies," Dr. Tuddenham said. "The primary goal behind the development of this new rFVIII was to reduce the overall immunogenic challenge (and resultant inhibitor formation) to the hemophilia patient during rFVIII replacement therapy. An essential part of this strategy was the development of a human rFVIII protein expressed in a human cell-based protein expression system instead of using existing hamster-derived cell lines."

The symposium highlighted the benefits of using a human cell-based protein; preclinical characterizations and some of the functional properties of the first recombinant factor VIII (rFVIII) from a human cell-line; and the planned global clinical development program with the new rFVIII derived from human cells. The investigational new drug application for Octapharma's human cell line rFVIII was filed in the U.S. in May 2008. Clinical trials started in Russia in Spring 2009 and are expected to start in the U.S. later this year. Additionally, Octapharma has other recombin
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