G - Physics – 01 – N
Patent
G - Physics
01
N
G01N 33/68 (2006.01)
Patent
CA 2603481
The invention relates to methods and products for the identification of a clinically significant immune response in subjects treated with a therapeutic protein. A first aspect of the invention relates to methods and compositions for identifying a clinically significant immune response in patients treated with therapeutic amounts of a VLA4 binding antibody (e.g., natalizumab) . A second aspect of the invention concerns the chronological details of sample collection for determining the titre of antibodies against the therapeutic protein, e.g. the collection of at least two samples at two different time points . A third aspect of the invention relates to the selection of the critical threshold level, which corresponds to the antibody titre of untreated patients increased by the double of the standard deviation of this control antibody titre.
La présente invention concerne des procédés et des produits pour identifier une réponse immunitaire cliniquement importante chez des sujets traités avec une protéine thérapeutique. Des aspects de cette invention concernent des procédés et des compositions pour identifier une réponse immunitaire cliniquement importante chez des sujets traités avec des quantités thérapeutiques d'un anticorps se liant à VLA4 (par ex. natalizumab).
Amaravadi Lakshmi
Barbour Robin Mcdaid
Lynn Frances
Panzara Michael
Subramanyam Meena
Biogen Idec Ma Inc.
Elan Pharmaceuticals Inc.
Gowling Lafleur Henderson Llp
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