Assays for measurement of type II collagen fragments in urine
AssigneePfizer Inc.
InventorsMary J. Saltarelli, Kimberly S. Johnson, Ivan G. Otterness
Life of this patent
Estimating the term…
Abstract
This invention provides novel methods for monitoring urine for type II collagen fragment using a combination of a capture antibody and a detection antibody, such that type II collagen is distinguished from other collagen fragments.
Claims35
A method for monitoring urine for type II collagen fragments, said method comprising:
- a) contacting said urine with a capture antibody, wherein said capture antibody binds specifically to type II collagen fragments, to the substantial exclusion of any binding to type I or III collagen fragments;
- b) contacting said urine with a detection antibody, wherein said detection antibody binds specifically to collagenase-generated collagen fragments, wherein said fragments comprise the sequences set forth in SEQ ID NO:1 or SEQ ID NO:2;
- and
- c) detecting the amount of type II collagen fragments bound to said capture and detection antibodies.
A kit for monitoring urine for type II collagen fragments, said kit comprising:
- a) a capture antibody, wherein said capture antibody binds specifically to type II collagen fragments, to the substantial exclusion of any binding to type I or III collagen fragments;
- b) a detection antibody, wherein said detection antibody binds specifically to collagenase-generated collagen fragments, wherein said fragments comprise the sequences set forth in SEQ ID NO:1 or SEQ ID NO:2;
- c) a container;
- and
- d) instructions describing a method of using said first antibody and said second antibody to monitor biological media for type II collagen fragments.
A method of diagnosing a patient for a disease state associated with the degradation of type II collagen, said method comprising the step of detecting the presence of atypically large amounts of type II collagen fragments in urine collected from said patient, wherein said fragments are detected using a detection antibody active against the sequences set forth in SEQ ID NOS:
- 1 and 2.
A method of performing a clinical trial to evaluate a drug believed to be useful in treating a disease state associated with the degradation of type II collagen, said method comprising:
- a) measuring the level of type II collagen fragments in urine collected from a set of patients;
- b) administering said drug to a first subset of said patients, and a placebo to a second subset of said patients;
- c) repeating step a) after the administration of said drug or said placebo;
- and
- d) determining if said drug is reducing the amount of type II collagen fragments present in said urine of said first subset of patients to a degree that is statistically significant as compared to any reduction occurring in said second subset of patients, wherein a statistically significant reduction indicates that said drug is useful in treating said disease state.
Dependencies are inferred from the claim text.