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07/04/13 5:15 PM

#131271 RE: entdoc #131270

Of critical importance re Humanized Antibodies: "Monoclonal antibody humanization is important for drugs that are to be administered multiple times. Research antibodies are typically made in mice/of mouse and are called "murine antibodies". Murine antibodies are not ideal for human clinical use because the patient can potentially recognize the murine antibody as foreign and may generate a Human Anti-Mouse Antibody (HAMA) immune response in an attempt to destroy the murine antibody. Monoclonal antibody "humanization" is a technique where specific regions of the mouse antibody not involved in target binding are replaced with human antibody building blocks, resulting in a final drug candidate that is approximately 93% human. The result is an antibody that has the targeting characteristics of the original mouse antibody but does not have enough of a mouse structure to be recognized by the human body as foreign. Therefore, humanized antibodies reduce or eliminate the HAMA response during treatment, making multiple treatments possible.