Drug – bio-affecting and body treating compositions – Immunoglobulin – antiserum – antibody – or antibody fragment,...
Reexamination Certificate
2011-03-22
2011-03-22
Navarro, Mark (Department: 1645)
Drug, bio-affecting and body treating compositions
Immunoglobulin, antiserum, antibody, or antibody fragment,...
C424S133100, C424S141100, C424S142100, C424S150100, C424S169100
Reexamination Certificate
active
07910096
ABSTRACT:
Human and humanized monoclonal antibodies which binds specifically to subunit A of Shiga like toxin II have been developed which are effective to prevent or ameliorate one or more symptoms of HUS in a human. Effective dosages for treatment or prevention range from approximately 0.1 to 5.0 mg of antibody/kg of patient weight. The examples demonstrate the preferred dosage ranges based on the pig model, and what is being tested in phase I clinical trials. Antibodies are preferably transfused over a period of two hours, although this will depend on the patient and the disease state at the time of treatment. Preferred dosages for treatment of humans are between 0.1 mg/kg-5.0 mg/kg of 5C120, or an equivalent dosage of another antibody to subunit A of STX2. In the most preferred embodiments, dosages of 0.1 mg/kg, 0.5 mg/kg, or 5.0 mg/kg of 5C12 (low dose, anticipated therapeutic dose based on animal data and high dose) are administered.
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Balakrishnan Ramaswamy
Donohue-Rolfe Arthur
Tzipori Saul
Navarro Mark
Pabst Patent Group LLP
Trustees of Tufts College
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