Biogen Ma Inc.

Biogen Idec Ma Inc.

Elan Pharmaceuticals, Inc.

Meena Subramanyam

Tatiana Plavina

Carmen Bozic

Gary Lewis Bloomgren

Sophia Lee

Robin McDaid Barbour

Eric M Wakshull

Julie Elizabeth Taylor

Amy Pace

Frances Lynn

Michael Panzara

Kenneth J Simon

Leonid Gorelik

Mia Marie Rushe

Lakshmi Amaravadi

Lakshimi Amaravadi

Eric Wakshull

The invention relates to methods of assessing a patient' s risk of developing Progressive multifocal leukoencephalopathy (PML).

Method of assessing risk of PML

The invention relates to methods and reagents for analyzing samples for the presence of JC virus antibodies.

Assay for JC virus antibodies

The invention relates to methods of assessing a patient's risk of developing Progressive multifocal leukoencephalopathy (PML).

Methods of treating a multiple sclerosis patient with anti-VLA-4 therapy

The invention relates to methods and products for the identification of a clinically significant immune response in subjects treated with a therapeutic protein. Aspects of the invention relate 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).

Methods and products for evaluating an immune response to a therapeutic protein

The disclosure relates to methods and reagents for analyzing samples for the presence of JC virus antibodies. Disclosed is a method that includes obtaining a biological sample from a subject (e.g., plasma, serum, blood, urine, or cerebrospinal fluid), contacting the sample with highly purified viral-like particles (HPVLPs) under conditions suitable for binding of a JCV antibody in the sample to an HPVLP, and detecting the level of JCV antibody binding in the sample to HPVLP. In one embodiment, determining the level of anti-JCV antibodies in the subject sample provides a method of identifying PML risk in a subject.

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.

The invention relates to methods and products for the identification of a clinically significant immune response in subjects treated with a therapeutic protein. Aspects of the invention relate 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.

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Stoneham, MA, United States of America

Meena Subramanyam