Biomarin Pharmaceutical Inc.

Medarex Inc.

Agy Therapeutics, Inc.

Erik Damien Foehr

Daniel J Chin

Mirella Gonzalez-Zulueta

Sabine Mueller

Bin Zhao

Augustus O Okhamafe

Alejandro Dorenbaum

Daniel I Oppenheimer

Sianna Castillo

Joleen White

Carlos Fabricio Santamaria

Lisa Argento Flay

Gary Taniguchi

William S Prince

Paul J Kostel

Paul John Kostel

Provided herein are methods of detecting the presence of a pegylated enzyme, an enzyme-specific antibody (e.g., a neutralizing antibody or of a particular isotype), or a polyethylene glycol (PEG)-specific antibody in a sample, such as a bodily fluid or tissue of a patient. In certain embodiments, the enzyme is phenylalanine ammonia-lyase (PAL), such as(Av) PAL administered to the patient as part of an enzyme substitution therapy for diseases or disorders, such as phenylketonuria (PKU), or cancer therapy.

Assays for detection of phenylalanine ammonia-lyase and antibodies to phenylalanine ammonia-lyase

The present invention is directed to treatment methods of administering tetrahydrobiopterin, including in oral dosage forms, in intravenous formulations, and with food. Also disclosed herein are biopterin assays for measuring the amount of biopterin and metabolites of biopterin in a sample.

Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring

The present invention relates to methods for screening body fluids or tissues for antibodies, including neutralizing and isotype-specific antibodies, against lysosomal enzymes administered as part of enzyme replacement therapy.

Assay for detection of antibodies to lysosomal enzymes

The present invention relates to the use of a protein that is differentially expressed in primary brain tumor tissues, as compared to normal brain tissues, as a biomolecular target for tumor treatment therapies. The protein is also expressed in tissues from adenocarcinoma, non-melanoma, and renal carcinoma cells. Immunotherapeutic and immunoimaging agents that specifically bind to an identified brain tumor target protein are provided. The present invention also provides compounds and pharmaceutically acceptable compositions for administration in the methods of the invention.

Use of biomolecular targets in the treatment and visualization of tumors

The present invention relates to the use of proteins that are differentially expressed in primary brain tumor tissues, as compared to normal brain tissues, as biomolecular targets for brain tumor treatment therapies. Specifically, the present invention relates to the use of immunotherapeutic and immunoimaging agents, which specifically bind to one or more of the identified brain tumor protein targets. The present invention also provides compounds and pharmaceutically acceptable compositions for administration in the methods of the invention. Nucleic acid probes specific for the spliced mRNA encoding these variants and affinity reagents specific for the novel proteins are also provided.

Use of biomolecular targets in the treatment and visualization of brain tumors

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San Rafael, CA, United States of America

Erik Damien Foehr