Abstract: In part, the disclosure relates to methods of treating fibrotic cancers by administering one or more Serum Amyloid Protein (SAP) agonists. In certain aspects, the method further comprises the conjoint administration of an anti-cancer therapeutic, e.g., a chemotherapeutic agent. In certain aspects, the disclosure relates to methods of treating myelofibrosis by administering an SAP agonist and optionally one or more anti-cancer therapeutic agents.

Abstract: The present invention provides methods and compositions for expanding T regulatory cells ex vivo or in vivo using one or more SAP agonists. The methods and compositions are useful in the treatment of autoimmune diseases and in preventing foreign graft rejection.

Abstract: The application provides methods for determining a patient's risk for developing fibrosis or a fibrosis-related disorder. Concentrations of C reactive protein (CRP) and serum amyloid protein (SAP) are measured from a biological sample to determine the SAP-to-CRP ratio. This ratio can then be compared with one or more SAP-to-CRP reference ratios to determine a patient's risk for developing a fibrosis related disorder. The diagnostic methods can also be used to determine the severity of fibrosis in a patient afflicted with such a disease. Furthermore, methods for treating patients having a fibrosis-related disorder are provided. For example, a patient that has a lower SAP-to-CRP ratio than one or more reference values may be treated with an SAP agonist and/or CRP antagonist to treat or prevent a fibrosis disorder. The methods may further comprise determining the R131/H131 polymorphism of Fc?RIIA as a risk factor for developing fibrosis or a fibrosis-related disorder.

Abstract: Polypeptides are susceptible to denaturation or enzymatic degradation in the blood, liver or kidney. Due to the low stability of some polypeptides, it has been required to administer polypeptide drugs in a sustained frequency to a subject in order to maintain an effective plasma concentration of the active substance. Furthermore, pharmaceutical compositions of therapeutic peptides preferably have a shelf-life of several years in order to be suitable for common use. However, peptide compositions are inherently unstable due to sensitivity towards chemical and physical degradation. In part, the invention provides SAP variant proteins, compositions, pharmaceutical preparations and formulations having a prolonged in vivo half-life, prolonged shelf-life, or rather increased in vitro stability, or increased manufacturing efficiency compared to human SAP. Advantages of increased plasma half-life include, but are not limited to, reducing the amount and/or frequency of dosing.

Abstract: One aspect of the present invention relates to the surprising discovery that modification of a glycan structure on a human SAP polypeptide can increase the biological activity of the SAP polypeptide relative to a corresponding sample of wild-type SAP isolated from human serum. The disclosure provides both variant human SAP polypeptides and methods for making the same. In particular, the present invention provides methods and compositions for in vitro and in vivo addition, deletion, or modification of sugar residues to produce SAP polypeptides, such as a human SAP polypeptide, having a desired glycosylation pattern.

Abstract: The current standard of care for the treatment of allergic airway diseases include short and long acting beta-agonists, and inhaled or systemic corticosteroids, cromolyn and xanthines that all have the potential of detrimental side-effects. The present invention describes a new mechanistic protein-based therapeutic approach for the treatment of allergic airway disease and diseases associated with excessive Th2 pathology. The present invention relates to the surprising discovery that serum amyloid P (SAP) demonstrates a therapeutic affect in the treatment of hypersensitive disorders.

Abstract: Functionalized pentraxin-2 (PTX-2) protomers and functionalized PTX-2 pentamers, methods for preparing functionalized PTX-2 protomers and functionalized PTX-2 pentamers, pharmaceutical compositions including functionalized PTX-2 pentamers, and methods for using the same are described herein.

Abstract: Functionalized pentraxin-2 (PTX-2) protomers and functionalized PTX-2 pentamers, methods for preparing functionalized PTX-2 protomers and functionalized PTX-2 pentamers, pharmaceutical compositions including functionalized PTX-2 pentamers, and methods for using the same are described herein.

Abstract: In certain aspects, the present invention provides compositions and methods for treating mucositis.

Abstract: Polypeptides are susceptible to denaturation or enzymatic degradation in the blood, liver or kidney. Due to the low stability of some polypeptides, it has been required to administer polypeptide drugs in a sustained frequency to a subject in order to maintain an effective plasma concentration of the active substance. Furthermore, pharmaceutical compositions of therapeutic peptides preferably have a shelf-life of several years in order to be suitable for common use. However, peptide compositions are inherently unstable due to sensitivity towards chemical and physical degradation. In part, the invention provides SAP variant proteins, compositions, pharmaceutical preparations and formulations having a prolonged in vivo half-life, prolonged shelf-life, or rather increased in vitro stability, or increased manufacturing efficiency compared to human SAP. Advantages of increased plasma half-life include, but are not limited to, reducing the amount and/or frequency of dosing.

Abstract: The disclosure relates to methods for delivery of serum amyloid P to the respiratory system. Pharmaceutical compositions comprising SAP suitable for respiratory delivery are also provided.

Abstract: Polypeptides are susceptible to denaturation or enzymatic degradation in the blood, liver or kidney. Due to the low stability of some polypeptides, it has been required to administer polypeptide drugs in a sustained frequency to a subject in order to maintain an effective plasma concentration of the active substance. Furthermore, pharmaceutical compositions of therapeutic peptides preferably have a shelf-life of several years in order to be suitable for common use. However, peptide compositions are inherently unstable due to sensitivity towards chemical and physical degradation. In part, the invention provides SAP variant proteins, compositions, pharmaceutical preparations and formulations having a prolonged in vivo half-life, prolonged shelf-life, or rather increased in vitro stability, or increased manufacturing efficiency compared to human SAP. Advantages of increased plasma half-life include, but are not limited to, reducing the amount and/or frequency of dosing.

Abstract: The present invention relates to improved methods of treating fibrotic or fibroproliferative disorders. Conjoint therapies are provided comprising the combination of one or more fibrocyte suppressors and one or more profibrotic factor antagonists or anti-fibrotic agents.

Abstract: Polypeptides are susceptible to denaturation or enzymatic degradation in the blood, liver or kidney. Due to the low stability of some polypeptides, it has been required to administer polypeptide drugs in a sustained frequency to a subject in order to maintain an effective plasma concentration of the active substance. Furthermore, pharmaceutical compositions of therapeutic peptides preferably have a shelf-life of several years in order to be suitable for common use. However, peptide compositions are inherently unstable due to sensitivity towards chemical and physical degradation. In part, the invention provides SAP variant proteins, compositions, pharmaceutical preparations and formulations having a prolonged in vivo half-life, prolonged shelf-life, or rather increased in vitro stability, or increased manufacturing efficiency compared to human SAP. Advantages of increased plasma half-life include, but are not limited to, reducing the amount and/or frequency of dosing.

Abstract: The present invention relates to improved methods of treating fibrotic or fibroproliferative disorders. Conjoint therapies are provided comprising the combination of one or more fibrocyte suppressors and one or more profibrotic factor antagonists or anti-fibrotic agents.

Abstract: Compositions and methods are provided for the treatment of fibrosis related disorders utilizing the ratio of the concentration of serum amyloid P(SAP) to C-reactive protein (CRP) in a patient. The methods may further comprise determining the R131/H131 polymorphism of Fc?RIIA. Diagnostic methods are also provided.

Abstract: In certain aspects, the present invention provides compositions and methods for treating mucositis.