The patent badge is an abbreviated version of the USPTO patent document. The patent badge does contain a link to the full patent document.
The patent badge is an abbreviated version of the USPTO patent document. The patent badge covers the following: Patent number, Date patent was issued, Date patent was filed, Title of the patent, Applicant, Inventor, Assignee, Attorney firm, Primary examiner, Assistant examiner, CPCs, and Abstract. The patent badge does contain a link to the full patent document (in Adobe Acrobat format, aka pdf). To download or print any patent click here.
Patent No.:
Date of Patent:
Jul. 18, 2017
Filed:
Jul. 14, 2014
Biogen MA Inc., Cambridge, MA (US);
Meena Subramanyam, Stoneham, MA (US);
Lakshmi Amaravadi, Natick, MA (US);
Eric Wakshull, Princeton, MA (US);
Frances Lynn, Somerville, MA (US);
Michael Panzara, Winchester, MA (US);
Robin McDaid Barbour, Walnut Creek, CA (US);
Julie Elizabeth Taylor, San Francisco, CA (US);
Biogen MA Inc., Cambridge, MA (US);
Abstract
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 VLA4 binding antibody (e.g., natalizumab). A second aspect of the invention concerns the chronological details of sample collection for determining the titer 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 titer of untreated patients increased by the double of the standard deviation of this control antibody titer.