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
International Classification:
G01N 33/535 G01N 33/53
US Classification:
435 792, 435 71
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 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.
Methods And Products For Evaluating An Immune Response To A Therapeutic Protein
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
Assignee:
Biogen Idec MA Inc. - Cambridge MA Elan Pharmaceuticals, Inc. - South San Francisco CA
International Classification:
A61K 39/395 G01N 33/566 A61P 37/00 C07K 16/42
US Classification:
4241331, 5303872, 435 792
Abstract:
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.
Leonid Gorelik - Quincy MA, US Kenneth J. Simon - Cambridge MA, US Meena Subramanyam - Stoneham MA, US Mia Marie Rushe - Everett MA, US
International Classification:
C12Q 1/70 C12N 7/04
US Classification:
435 5, 435236
Abstract:
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.
- Cambridge MA, US Carmen BOZIC - Newton MA, US Sophia LEE - Waltham MA, US Amy PACE - Brookline MA, US Tatiana PLAVINA - North Reading MA, US Meena SUBRAMANYAM - Stoneham MA, US
International Classification:
G01N 33/68 G01N 33/569 C12N 7/00 C07K 16/28
Abstract:
The invention relates to methods of assessing a patient's risk of developing Progressive multifocal leukoencephalopathy (PML).
- Cambridge MA, US Kenneth J. SIMON - Cambridge MA, US Meena SUBRAMANYAM - Stoneham MA, US Mia Marie RUSHE - Everett MA, US
International Classification:
G01N 33/543
Abstract:
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.
- Cambridge MA, US Carmen BOZIC - Newton MA, US Sophia LEE - Waltham MA, US Amy PACE - Brookline MA, US Tatiana PLAVINA - North Reading MA, US Meena SUBRAMANYAM - Stoneham MA, US
International Classification:
G01N 33/68 G01N 33/569 C12N 7/00 C07K 16/28
Abstract:
The invention relates to methods of assessing a patient's risk of developing Progressive multifocal leukoencephalopathy (PML).
- Cambridge MA, US Kenneth J. Simon - Cambridge MA, US Meena Subramanyam - Stoneham MA, US Mia Marie Rushe - Everett MA, US
International Classification:
G01N 33/569
Abstract:
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.