The Collaborative Group, Ltd.

Biogen Ma Inc.

Biogen Idec Ma Inc.

Elan Pharmaceuticals, Inc.

Biopolymer Engineering Pharmaceutical, Inc.

Eric M Wakshull

Janet W Zimmerman

William M Mackin

Robin McDaid Barbour

Meena Subramanyam

Julie Elizabeth Taylor

Michael Panzara

Frances Lynn

Lakshmi Amaravadi

Leslie W Fisette

Lakshimi Amaravadi

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 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.

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.

A preparation containing a receptor for underivatized, aqueous soluble &bgr;(1-3)-glucan is disclosed, along with characterization of the receptor for underivatized, aqueous soluble &bgr;(1-3)-glucan. Also described are assays for identifying agents which alter the effect of underivatized, aqueous soluble &bgr;(1-3)-glucan on activation of signal transduction pathways and agents identified thereby, as well as assays for assessing the specificity of carbohydrate:glycolipid interactions.

Assay for binding between carbohydrate and glycolipid

Methods of isolating &bgr;(1-3)-glucan or &bgr;(1-3)-glucan-containing organisms in a sample, or of detecting the presence of &bgr;(1-3)-glucan or &bgr;(1-3)-glucan-containing organisms in a sample, utilizing binding agents for &bgr;(1-3)-glucan, such as LacCer, GalCer, globotriaosylceramide and asialoganglioside-GM1, are described. Methods of diagnosing fungal infection, by detecting &bgr;(1-3)-glucan or &bgr;(1-3)-glucan-containing organisms, are also described. Antibodies and kits useful in the methods are also disclosed.

&bgr;(1-3)-glucan diagnostic assays

A preparation containing a receptor for underivatized, aqueous soluble .beta.(1-3)-glucan is disclosed, along with characterization of the receptor for underivatized, aqueous soluble .beta.(1-3)-glucan. Also described are assays for identifying agents which alter the effect of underivatized, aqueous soluble .beta.(1-3)-glucan on activation of signal transduction pathways and agents identified thereby.

Receptor for underivatized aqueous soluble .beta.(1-3)-glucan

Activation of signal transduction by underivatized, aqueous soluble      .

Methods of isolating .beta.(1-3)-glucan or .beta.(1-3)glucan-containing organisms in a sample, or of detecting the presence of .beta.(1-3)-glucan or .beta.(1-3)-glucan-containing organisms in a sample, utilizing binding agents for .beta.(1-3)-glucan, such as LacCer, GalCer, globotriaosylceramide and asialoganglioside-GM1, are described. Methods of diagnosing fungal infection, by detecting .beta.(1-3)-glucan or .beta.(1-3)-glucan-containing organisms, are also described. Antibodies and kits useful in the methods are also disclosed.

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Princeton, MA, United States of America

Eric M Wakshull